In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research. This analysis not only highlights the financial success of these drugs but also sheds light on the therapeutic advancements and innovation driving patient outcomes in the oncology domain.
As we delve into the specifics of these best-selling oncology drugs, we uncover the underlying factors contributing to their market dominance, from clinical efficacy and safety profiles to strategic market positioning and patient accessibility. This article serves as a resource for healthcare professionals, life sciences researchers and industry enthusiasts seeking to stay informed of the latest developments and success stories in oncology therapeutics.
Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data.
1. Keytruda (Pembrolizumab)
Keytruda 2022 sales: $20.937 billion
Company/Developer: Merck
Date of first US Food and Drug Administration (FDA) approval: September 4, 2014
Indications Keytruda is FDA-approved for: Breast cancer, melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell cancer, urothelial carcinoma, microsatellite instability-high or a mismatch repair deficient solid tumor, colon or rectal cancer, esophageal or certain gastroesophageal junction carcinomas, cervical cancer, renal cell carcinoma, endometrial carcinoma and cutaneous squamous cell carcinoma.
Price of Keytruda: $11,115.04 for each indicated dose when given for three weeks and $22,230.08 when administered every six weeks.
Why it did so well: Keytruda was first approved in 2014 for advanced melanoma and a decade later, it has approvals in 39 indications across over 20 different cancer types in the US, with its most recent in late-stage cervical cancer granted by the FDA in January 2024. The programmed death receptor-1 (PD-1) immune checkpoint inhibitor is not only Merck’s reigning blockbuster but also remains one of the best-selling drugs globally, and is expected to be the world’s top seller in 2024. Keytruda has proven to be such a mammoth success given its effectiveness across a range of different cancers, particularly in challenging, advanced cancers. It has demonstrated significant effectiveness as a monotherapy as well as in combination therapies, lending to its versatility. Moreover, its enduring effectiveness was highlighted by recent findings presented at the European Society for Medical Oncology (ESMO) annual meeting last September. In the studies, a combination of Keytruda and chemotherapy led to nearly 20 percent of patients with NSCLC surviving for five years.
2. Revlimid (Lenalidomide)
Revlimid 2022 sales: $9.978 billion
Company/Developer: Bristol Myers Squibb
Date of first FDA approval: December 27, 2005
Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.
Price of Revlimid: A supply of 28 oral 2.5 mg capsules is $24,576.
Why it did so well: Despite Revlimid sales having fallen in 2023, largely due to generic competition, it continues to be Bristol Myers Squibb’s top-selling drug. Its success can be attributed to its effectiveness in difficult to treat blood cancers such as multiple myeloma in which it has a more than 70 percent response rate. Lenalidomide is a more powerful analog of thalidomide, a cereblon E3 ligase modulator, which inhibits tumor cell proliferation, angiogenesis and tumor-secreted cytokines.
3. Opdivo (Nivolumab)
Opdivo 2022 sales: $9.299 billion
Company/Developer: Bristol Myers Squibb
Date of first FDA approval: December 22, 2014
Indications Opdivo is FDA-approved for: Melanoma, NSCLC, small cell lung cancer (SCLC), malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) metastatic colorectal cancer, hepatocellular carcinoma, esophageal cancer, gastric cancer and gastroesophageal junction cancer.
Price of Opdivo: An intravenous solution (10 mg/mL) is around $1,297 for a supply of 4 mL.
Why it did so well: Opdivo is a PD-1 checkpoint inhibitor which found early success in melanoma that it continued to build on with subsequent approvals in other cancers, most notably NSCLC including metastatic disease for which there were limited treatment options previously. PD-1 checkpoint inhibitors like Opdivo and Keytruda have been transformative in oncology, with Keytruda having had the edge due to having approvals in several more indications than Opdivo and strong clinical trial results, including as a first-line treatment in combination with chemotherapy. Nevertheless, Opdivo continues to hold strong and Bristol Myers Squibb filed an application with the FDA in December for Opdivo in combination with cisplatin chemotherapy as a first-line treatment in advanced urothelial carcinoma.
4. Imbruvica (Ibrutinib)
Imbruvica 2022 sales: $8.352 billion
Company/Developer: Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc., which is wholly owned by Johnson & Johnson
Date of first FDA approval: November 13, 2013
Indications Imbruvica is FDA-approved for: Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion, Waldenström’s macroglobulinemia (WM), treatment of pediatric patients one year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.
Price of Imbruvica: $597 per capsule/tablet.
Why it did so well: Imbruvica was a game changer for CLL when it was first approved in 2013. A decade later, it remains a first-line treatment for the cancer. As of early 2019, the National Comprehensive Cancer Network (NCCN) recommends Imbruvica as a preferred regimen for the initial treatment of CLL/SLL. Sales of the Bruton’s tyrosine kinase (BTK) inhibitor grew 5.8 percent from 2021 to 2022 for Janssen. The drug faced a significant setback in December when the FDA pulled Imbruvica’s approvals for MCL and marginal zone lymphoma, as postmarketing trials did not verify the clinical benefit of ibrutinib for the indications, according to the agency. Pharmacyclics requested to voluntarily withdraw the approvals and decided to forgo an opportunity for a hearing.
5. Darzalex (Daratumumab)
Darzalex 2022 Sales: $7.977 billion
Company/Developer: Janssen Biotech, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson
Date of first FDA approval: November 16, 2015
Indications Darzalex is FDA-approved for: Multiple myeloma
Price of Darzalex: The price of Darzalex intravenous solution (20 mg/mL) is around $714 for a supply of 5 mL.
Why it did so well: Darzalex was the first human anti-CD38 monoclonal antibody approved by the FDA for multiple myeloma. The worldwide net trade sales of Darzalex were $2.26 billion in the first quarter of 2023. Despite Bristol Myers Squibb’s Revlimid remaining the top-selling drug for multiple myeloma for several years now, Darzalex is not too far behind. While Revlimid’s projected global sales in 2024 are expected to reach $11.93 billion, Darzalex is expected to bring in over $10 billion this year.
6. Tagrisso (Osimertinib)
Tagrisso 2022 sales: $5.444 billion
Company/Developer: AstraZeneca
Date of first FDA approval: November 13, 2015
Indications Tagrisso is FDA-approved for: Tagrisso is a tyrosine kinase inhibitor (TKI) prescribed for the following conditions: Adjuvant therapy following tumor resection in adult patients with NSCLC characterized by epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as identified through an FDA-approved test; initial treatment for adult patients with metastatic NSCLC exhibiting EGFR exon 19 deletions or exon 21 L858R mutations, as detected through an FDA-approved test; and treatment of adult patients with metastatic NSCLC positive for EGFR T790M mutation, as confirmed by an FDA-approved test, whose condition has progressed during or following EGFR TKI therapy.
Price of Tagrisso: The yearly expense for osimertinib adjuvant therapy would amount to $107,557, assuming patients remain on the treatment for an entire year.
Why it did so well: Tagrisso has received approval as a stand-alone treatment in over 100 countries, including the US, European Union (EU), China and Japan. Tagrisso has been used to treat almost 700,000 patients across its indications worldwide.
7. Ibrance (Palbociclib)
Ibrance 2022 sales: $5.120 billion
Company/Developer: Pfizer
Date of first FDA approval: February 3, 2015
Indications Ibrance is FDA-approved for: Ibrance is a kinase inhibitor prescribed for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. It is administered in combination with either: an aromatase inhibitor as the initial endocrine-based therapy in postmenopausal women or in men; or fulvestrant in patients experiencing disease progression following endocrine therapy.
Price of Ibrance: According to Pfizer, the current list price as of January 15, 2024, for 28 days of treatment with Ibrance (21 capsules) is $15,077.73.
Why it did so well: In the year 2022, Ibrance achieved sales of $3.37 billion in the US alone. It holds approvals in over 90 countries and has been prescribed to over 200,000 patients worldwide.
8. Xtandi (Enzalutamide)
Xtandi 2022 sales: $5.037 billion
Company/Developer: Astellas Pharma US and Pfizer
Date of first FDA approval: August 31, 2012
Indications Xtandi is FDA-approved for: Xtandi is an androgen receptor inhibitor prescribed for the treatment of patients with castration-resistant prostate cancer; metastatic castration-sensitive prostate cancer; and non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.
Price of Xtandi: Xtandi’s wholesale cost is between $160,000 and $180,000 per patient a year.
Why it did so well: Currently, Xtandi holds approval for one or more of the conditions noted above in over 100 countries, including the US, the EU and Japan. Globally, Xtandi has been used to treat over one million patients. For the fiscal year that ended in March 2023, Xtandi contributed 661 billion Japanese yen (around $4.8 billion USD) to Astellas’ sales.
9. Perjeta (Pertuzumab)
Perjeta 2022 sales: $4.467 billion
Company/Developer: Genentech (Roche)
Date of first FDA approval: June 8, 2012
Indications Perjeta is FDA-approved for: Perjeta is a humanized monoclonal antibody specifically designed for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. It is administered in combination with trastuzumab (another targeted therapy) and docetaxel (a type of chemotherapy).
Price of Perjeta: The annual price for the combined treatment of Perjeta and Herceptin is $158,000, whereas the price for Herceptin when used solo is $75,000.
Why it did so well: Notably in 2020, Perjeta sales reached $4.2 billion, reflecting a 19 percent increase, primarily attributed to expanding market presence in China.
10. Tecentriq (Atezolizumab)
Tecentriq 2022 sales: $4.063 billion
Company/Developer: Genentech (Roche)
Date of first FDA approval: May 18, 2016
Indications Tecentriq is FDA-approved for: Tecentriq is a programmed death-ligand 1 (PD-L1) blocking antibody approved for the treatment of various cancers, including NSCLC, SCLC, hepatocellular carcinoma, melanoma and alveolar soft part sarcoma.
Price of Tecentriq: Tecentriq’s list price is $12,500.
Why it did so well: Tecentriq, initially approved in the US in 2016, achieved sales exceeding $3 billion in 2021. Tecentriq is approved in the US, EU and various other countries globally, either alone or in combination with targeted therapies and/or chemotherapies in various forms of NSCLC, SCLC, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma.
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11. Lynparza (Olaparib)
Lynparza 2022 sales: $3.754 billion
Company/Developer: AstraZeneca and Merck
Date of first FDA approval: December 19, 2014
Indications Lynparza is FDA-approved for: Lynparza stands as a pioneering poly (ADP-ribose) polymerase (PARP) inhibitor, marking the forefront of its class. It represents the inaugural targeted therapy designed to impede the DNA damage response (DDR) in cells or tumors exhibiting a deficiency in homologous recombination repair (HRR), notably those with mutations in BRCA1 and/or BRCA2 or those where deficiency is induced by other agents, such as DNA-damaging chemotherapies. Lynparza has indications in ovarian, breast, pancreatic and prostate cancers.
Price of Lynparza: The net price of Lynparza has experienced a substantial surge in recent years, escalating from approximately $199 per daily treatment (600 mg) in 2015 to exceeding $582 in 2021.
Why it did so well: Lynparza has secured approvals across various countries for multiple tumor types. Lynparza, a collaborative development and commercialization effort by AstraZeneca and Merck, has been administered to over 75,000 patients across the globe.
12. Pomalyst (Pomalidomide)
Pomalyst 2022 sales: $3.497 billion
Company: Bristol Myers Squibb
Date of first FDA approval: February 8, 2013
Indications Pomalyst is FDA-approved for: Pomalyst is a thalidomide analogue prescribed for patients with multiple myeloma who have undergone at least two previous treatments, including lenalidomide and bortezomib, and have exhibited disease progression either during or within 60 days of completing the last therapy.
Pomalyst is also prescribed for the treatment of adults with AIDS-related Kaposi sarcoma (KS) who have not responded to highly active antiretroviral therapy (HAART), or for those with KS who do not have HIV. This use of Pomalyst has received FDA accelerated approval, primarily based on overall response rate. The ongoing approval for this specific indication depends on the confirmation and detailed reporting of Pomalyst’s clinical benefits in subsequent trials.
Price of Pomalyst: Bristol Myers Squibb has set the unit price of Pomalyst (1mg capsule) to $949.99.
Why it did so well: Pomalyst stands as a key revenue driver for Bristol Myers Squibb, contributing nearly $3.5 billion to its total revenue of $46.16 billion in 2022. For the three months ended September 30, 2023, Pomalyst/Imnovid had generated $872 million worldwide for Bristol Myers Squibb.
13. Imfinzi (Durvalumab)
Imfinzi 2022 sales: $2.784 billion
Company/Developer: AstraZeneca
Date of first FDA approval: May 1, 2017
Indications Imfinzi is FDA-approved for: Imfinzi is a PD-L1 blocking antibody prescribed for the treatment of various cancers, including NSCLC, SCLC, biliary tract cancer and hepatocellular carcinoma.
Price of Imfinzi: Imfinzi costs around $180,000 annually.
Why it did so well: Imfinzi recorded sales of $3.1 billion in the initial nine months of 2023, marking a substantial 56 percent year-over-year increase. Since receiving its initial approval in May 2017, Imfinzi has been administered to over 150,000 patients. Imfinzi has received approval for the treatment of extensive-stage SCLC in various countries globally, including the US, EU, Japan, China and many others.
14. Lenvima (Lenvatinib)
Lenvima 2022 sales: $2.724 billion
Company/Developer: Eisai
Date of first FDA approval: February 13, 2015
Diseases Lenvima is FDA-approved to treat: Lenvima is a multi-receptor TKI indicated for the treatment of thyroid cancer, renal cell carcinoma, hepatocellular carcinoma and endometrial carcinoma.
Price of Lenvima: In 2018, Eisai Co Ltd announced that it would set the price of its cancer drug Lenvima at approximately $17,000 for a one-month supply before factoring in discounts.
Why it sold so well: As per the company’s statement, Lenvima generated global sales of $1.05 billion for the six months ending on September 30, 2023. Lenvima is approved in over 80 countries for hepatocellular carcinoma, in over 65 countries for renal cell carcinoma and in over 50 countries for endometrial carcinoma.
15. Verzenio (Abemaciclib)
Verzenio 2022 sales: $2.483 billion
Company/Developer: Eli Lilly and Company
Date of first FDA approval: September 28, 2017
Indications Verzenio is FDA-approved for: Verzenio (abemaciclib) is a targeted therapy classified as a CDK4/6 inhibitor, and it is administered in the form of a nonchemotherapy oral tablet. It is prescribed for the treatment of metastatic breast cancer in patients with HR-positive/HER2-negative status.
Price of Verzenio: The list price of Verzenio is $15,405.72 per month; however, the actual amount patients pay will largely depend on their insurance plan.
Why it did so well: In the third quarter of 2023, global revenue from Verzenio surged by 68 percent compared to the same period in 2022, reaching $1.04 billion. US revenue experienced a notable 65 percent increase, totaling $684.6 million in Q3 2023, primarily attributed to heightened demand and elevated realized prices. Internationally, revenue reached $355.7 million in Q3 2023, marking a 75 percent increase, driven by increased demand.
The benefits of Verzenio are supported by promising clinical data. In the clinical trial that led to the FDA approval, patients receiving Verzenio with fulvestrant demonstrated a progression-free survival of approximately 16.4 months, while those on a placebo with fulvestrant had a progression-free survival of 9.3 months. In this trial, around 20 percent of patients treated with Verzenio experienced complete or partial shrinkage of their tumors, with the effect lasting approximately nine months.
16. Herceptin (Trastuzumab)
Herceptin 2022 sales: $2.341 billion
Company/Developer: Genentech (Roche)
Date of first FDA approval: September 25, 1998
Indications Herceptin is FDA-approved for: Herceptin, a HER2/neu receptor antagonist, is prescribed for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Price of Herceptin: An annual course of Herceptin treatment costs about $70,000.
Why it did so well: Herceptin, representing a 25-year legacy of innovation, holds the distinction of being the first fully humanized antibody approved by the FDA in 1998. In the pivotal phase III trial that underpinned its approval, patients with treatment-naïve, HER2-overexpressing breast tumors experienced a prolonged time to disease progression, an extended duration of response and a 20 percent lower risk of death when treated with chemotherapy plus trastuzumab, compared to those receiving chemotherapy alone.
17. Avastin (Bevacizumab)
Avastin 2022 sales: $2.319 billion
Company/Developer: Genentech (Roche)
Date of first FDA approval: February 26, 2004
Indications Avastin is FDA-approved for: Avastin (bevacizumab) is a recombinant humanized monoclonal IgG1 antibody for the treatment of NSCLC, colorectal cancer, peritoneal cancer, glioblastoma, ovarian cancer, cervical cancer, fallopian tube cancer, renal cell carcinoma and hepatocellular carcinoma.
Price of Avastin: The cost of Avastin was reported to be £1,848.8 ($2,356.5 USD) per month for a 70 kg patient.
Why it did so well: In 2022, Avastin was Roche’s eighth best-selling drug, but as expected, the impact of biosimilars caused the sales of this cancer medicine to decrease by 28 percent compared to 2021. Currently, there are currently three Avastin biosimilars available, Amgen’s Mvasi (bevacizumab-awwb), Pfizer’s Zirabev (bevacizumab-bvzr) and Amneal Pharmaceuticals’ Alymsys (bevacizumab-maly).
18. Kadcyla (Ado-Trastuzumab Emtansine)
Kadcyla 2022 sales: $2.273 billion
Company/Developer: Genentech (Roche)
Date of first FDA approval: February 22, 2013
Indications Kadcyla is FDA-approved for: Kadcyla is specifically prescribed for patients with HER2-positive metastatic breast cancer who have previously undergone treatment with trastuzumab and a taxane, either individually or in combination. Kadcyla is also approved as an adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.
Price of Kadcyla: The cost of Kadcyla treatment was reported to be $9,800 per month, totaling $94,000 for a standard course of therapy.
Why it did so well: In 2021, Kadcyla achieved global sales amounting to $2.18 billion, establishing itself as the most commercially successful antibody drug conjugate (ADC). The safety and efficacy of Kadcyla were assessed in a clinical study involving 991 patients randomly allocated to receive either Kadcyla or lapatinib plus capecitabine. Those treated with Kadcyla exhibited a median progression-free survival of 9.6 months, in contrast to 6.4 months for patients treated with lapatinib plus capecitabine. Regarding median overall survival, the Kadcyla group demonstrated 30.9 months, whereas the lapatinib plus capecitabine group showed 25.1 months.
19. Sprycel (Dasatinib)
Sprycel 2022 sales: $2.165 billion
Company/Developer: Bristol Myers Squibb
Date of first FDA approval: June 28, 2006
Indications Sprycel is FDA-approved for: Sprycel is an orally administered TKI indicated for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) and Ph+ acute lymphoblastic leukemia (ALL).
Price of Sprycel: The list price of Sprycel is $18,246 per month.
Why it did so well: In 2022, Sprycel generated global revenues of $578 million, reflecting a four percent growth compared to the figures recorded in 2021. Since its introduction in 2006, over 45,000 patients have been treated with Sprycel. In a chronic phase CML study comprising 186 enrolled patients (one of the trials that led to the FDA approval), the findings demonstrated efficacy in the primary endpoint. Sprycel achieved a major cytogenetic response (MCyR) in 45 percent of participants, including complete cytogenic response (CCyR, defined as the absence of detectable Ph+ cells) in 33 percent of subjects. Additionally, a complete hematologic response (CHR) was attained in 90 percent of the participants.
20. Yervoy (Ipilimumab)
Yervoy 2022 sales: $2.131 billion
Company/Developer: Bristol Myers Squibb
Date of first FDA approval: March 25, 2011
Indications Yervoy is FDA-approved for: Yervoy marks the initial FDA-approved treatment for unresectable or metastatic melanoma. Yervoy, in conjunction with Opdivo, is also employed for treating various cancers. These include advanced renal cell carcinoma, NSCLC, MSI-H/dMMR metastatic colorectal cancer, hepatocellular carcinoma and malignant pleural mesothelioma.
Price of Yervoy: Treatment with combination of Yervoy and Opdivo, approved by the FDA for advanced or inoperable melanoma, costs around $256,000 annually for patients who respond to the treatment.
Why it did so well: In 2022, Bristol Myers Squibb reported $2.131 billion in sales for Yervoy, reflecting a five percent increase in revenue compared to 2021. As the first FDA-approved cancer immunotherapy for melanoma, it has demonstrated a substantial improvement in overall survival during clinical trials. Yervoy has received approval in over 50 countries for the treatment of unresectable or metastatic melanoma. Additionally, there is an extensive and active development program underway for Yervoy, covering a variety of tumor types.
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21. Calquence (Acalabrutinib)
Calquence 2022 sales: $2.057 billion
Company/Developer: AstraZeneca
Date of first FDA approval: October 31, 2017
Indications Calquence is FDA-approved for: Calquence stands out as a highly selective and potent inhibitor of Bruton tyrosine kinase (BTK), designed for the treatment of MCL as well as CLL or SLL.
Price of Calquence: The list price of Calquence is $14,259 per month.
Why it did so well: In 2022, Calquence recorded sales of $2.057 billion, driven by heightened demand and increased patient market share in the US and Europe. Calquence has been administered to 50,000 patients globally. In the EU and several other countries, it is authorized specifically for CLL, and in Japan, it’s approved for use in cases of relapsed or refractory CLL and SLL.
22. Xgeva (Denosumab)
Xgeva 2022 sales: $2.014 billion
Company/Developer: Amgen
Date of first FDA approval: November 18, 2010
Indications Xgeva is FDA-approved for: Xgeva is a RANK ligand (RANKL) inhibitor prescribed for preventing skeletal-related events in patients with multiple myeloma and those with bone metastases from solid tumors. Additionally, Xgeva is indicated for the treatment of giant cell tumor of the bone and for managing hypercalcemia of malignancy that is refractory to bisphosphonate therapy.
Price of Xgeva: The list price of Xgeva is $3,194.43 per dose.
Why it did so well: According to Amgen’s financial results for the third quarter of 2023, Xgeva sales experienced a five percent year-over-year increase, attributed to a higher net selling price. The estimated US national expense for managing metastatic bone disease stands at $12.6 billion. This figure represents 17 percent of the total $74 billion direct medical costs as projected by the National Institutes of Health (NIH), indicating that metastatic bone disease plays a major role in driving the overall costs in oncology.
23. Venclexta (Venetoclax)
Venclexta 2022 sales: $2.009 billion
Company/Developer: AbbVie
Date of first FDA approval: April 11, 2016
Indications Venclexta is FDA-approved for: Venclexta is approved for the treatment of adult patients diagnosed with CLL or SLL. Additionally, it is indicated for use in combination with azacitidine, decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults aged 75 and older or for patients with health conditions that make intensive induction chemotherapy unsuitable.
Price of Venclexta: The wholesale acquisition cost of a 30-day supply of Venclexta (400 mg/day) is $15,267.49.
Why it did so well: According to the AbbVie’s third-quarter 2023 financial results, the global Venclexta net revenues were $590 million, an increase of 14.6 percent on a reported basis, or 14.0 percent on an operational basis. Venclexta is approved in more than 80 countries.
24. Erleada (Apalutamide)
Erleada 2022 sales: $1.881 billion
Company/Developer: Janssen Pharmaceuticals
Date of first FDA approval: February 14, 2018
Indications Erleada is FDA-approved for: Erleada is an androgen receptor inhibitor approved for treating patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and those with metastatic castration-sensitive prostate cancer (mCSPC).
Price of Erleada: Erleada is considerably more expensive than the majority of prescription drugs, with the average cost of 120 tablets exceeding $12,000.
Why it did so well: Erleada received FDA approval for nmCRPC in February 2018, and received FDA approval for mCSPC in September 2019. To date, more than 100,000 patients worldwide have been treated with Erleada.
25. Zytiga (Abiraterone Acetate)
Zytiga 2022 sales: $1.770 billion
Company/Developer: Janssen Biotech
Date of first FDA approval: April 28, 2011
Indications Zytiga is FDA-approved for: Zytiga (abiraterone acetate), in combination with prednisone, is prescribed for treating patients with metastatic castration-resistant prostate cancer (CRPC) and metastatic high-risk castration-sensitive prostate cancer (CSPC).
Price of Zytiga: A standard treatment of Zytiga is priced at around $10,000 per month.
Why it did so well: Initially approved by the FDA in 2011 for patients with metastatic CRPC who had undergone prior chemotherapy, abiraterone acetate with prednisone saw its indication expanded in 2012 to include patients with metastatic CRPC and later in 2018 for patients with metastatic high-risk CSPC. Since receiving its initial approval in Europe in 2011, abiraterone acetate, used in conjunction with prednisone or prednisolone, has gained approval in over 105 countries. To date, it has been prescribed to over 700,000 patients globally.
26. Tafinlar (Dabrafenib/Trametinib)
Tafinlar 2022 sales: $1.770 billion
Company/Developer: Novartis Pharmaceuticals/GSK
Date of first FDA approval: May 29, 2013
Indications Tafinlar is FDA-approved for: Tafinlar is a kinase inhibitor approved for independent use in patients with diagnosed unresectable or metastatic melanoma displaying the BRAF V600E mutation, identified through an FDA-approved test. It is also indicated for the treatment of NSCLC, thyroid cancer, solid tumors and low-grade glioma with BRAF V600 mutations.
Price of Tafinlar: The cost for Tafinlar (oral capsule, 50 mg) is around $11,912 for 120 capsules.
Why it did so well: According to recent financial reports from Novartis, the combined sales of Tafinlar and Mekinist have reached $482 million in the third quarter of 2023, indicating an eight percent increase compared to the same time period in 2022. This growth is attributed to increased demand in BRAF+ adjuvant melanoma and NSCLC indications, particularly in the US and emerging growth markets.
27. MabThera/Rituxan (Rituximab)
MabThera 2022 sales: $1.747 billion
Company/Developer: The drug was developed by Biogen and is co-promoted by Genentech, a subsidiary of Roche Group.
Date of first FDA approval: November 26, 1997
Indications it is FDA-approved for: MabThera is indicated for the treatment of patients with non-Hodgkin’s lymphoma, CLL, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris.
Price of MabThera: Rituxan intravenous solution (10 mg/mL) costs around $999 for a supply of 10 mL.
Why it did so well: MabThera was the first therapeutic monoclonal antibody to target cells with the CD20 marker on their surface. It has been one of the most successful oncology drugs of all time. It was protected by patents up until 2013, after which sales have consistently declined due to several biosimilars being available on the market. It still remained one of Roche’s top-selling oncology drugs despite several biosimilars being available on the market.
28. Alecensa (Alectinib)
Alecensa 2022 sales: $1.653 billion
Company/Developer: Genentech/Roche
Date of first FDA approval: December 11, 2015
Indications Alecensa is FDA-approved for: Alecensa is approved for the treatment of ALK-positive NSCLC.
Price of Alecensa: Alecensa costs around $19,531 for a supply of 240 capsules (150 mg each).
Why it did so well: Alecensa is currently approved in over 80 countries as a first-line treatment for advanced (metastatic) ALK-positive NSCLC. It is also approved in over 90 countries for the treatment of ALK-positive advanced NSCLC patients whose disease has worsened after or who could not tolerate treatment with crizotinib. Alecensa is approved in Japan for the additional indication of recurrent or refractory ALK fusion gene-positive anaplastic large-cell lymphoma. Alecensa is not currently available in generic form.
The global uptake of Alecensa continued with a 10 percent increase in sales as per Roche’s half-yearly report for 2023. Additionally, Roche is trying to become the first company to get approval for an ALK inhibitor in early-stage NSCLC and seems to be firmly in front of its rivals with that plan, as there is no indication that any of the other companies are testing their ALK inhibitors in this setting.
29. Somatuline (Lanreotide)
Somatuline 2022 sales: $1.306 billion
Company/Developer: Ipsen
Date of first FDA approval: August 30, 2007
Indications it is FDA-approved for: Somatuline is a long-acting somatostatin analogue indicated for the treatment of gastroenteropancreatic neuroendocrine tumors, acromegaly and carcinoid syndrome.
Price of Somatuline: Somatuline Depot subcutaneous solution (60 mg/0.2 mL) costs around $6,420 for a supply of 0.2 mL.
Why it did so well: Somatuline Depot is the first and only FDA-approved treatment for adults to both slow the growth of metastatic gastrointestinal and pancreatic neuroendocrine tumors and treat carcinoid syndrome to reduce the need for the use of short-acting somatostatin medicine. Somatuline autogel releases the active substance with no excipient other than water over a period of at least 28 days, thus requiring just one injection per month compared with the two or three injections previously necessary. Additionally, it is available in a pre-filled syringe, eliminating any need for reconstitution and thus enabling patients to have freedom of easy administration.
30. Kyprolis (Carfilzomib)
Kyprolis 2022 sales: $1.247 billion
Company/Developer: Amgen
Date of first FDA approval: July 20, 2012
Indications Kyprolis is FDA-approved for: Kyprolis is a proteasome inhibitor used to treat patients with relapsed or refractory multiple myeloma.
Price of Kyprolis: The cost for Kyprolis intravenous powder for injection (10 mg) is around $558 for a supply of one powder for injection.
Why it did so well: According to Amgen’s third quarter results for 2023, Kyprolis sales increased 10 percent year-over-year for the third quarter of 2023, primarily driven by eight percent volume growth. The main factor driving the growth of the Kyprolis market is the rise in the number of people suffering from blood cancer. Carfilzomib has several advantages over traditional cancer treatment technologies, such as its improved efficacy, decreased adverse reactions compared with proteasome inhibitor therapy and reduced possibility of heart failure and dyspnoea. This, in turn, drives the Kyprolis market growth. Currently, the number of approved treatments for myeloma in the world is limited, which further fuels the revenue growth.
31. Sandostatin (Octreotide)
Sandostatin 2022 sales: $1.238 billion
Company/Developer: Novartis
Date of first FDA approval: October 21, 1988
Indications Sandostatin is FDA-approved for: Sandostatin is a synthetic protein closely resembling the natural hormone somatostatin in the human body. It is prescribed for the treatment of acromegaly and to alleviate episodes of flushing and watery diarrhea induced by cancerous tumors, specifically those associated with carcinoid syndrome, as well as tumors known as vasoactive intestinal peptide tumors (VIPomas).
Price of Sandostatin: The cost for Sandostatin injectable solution (50 mcg/mL) is around $158 for a supply of 10 mL.
Why it did so well: Although it lost patent protection outside of the US over a decade ago, Sandostatin still continues to generate significant sales globally. The main reason for this stellar revenue performance is that it is tough to produce, and a surge in the prevalence of neuroendocrine tumors and acromegaly drives the sales.
32. Kisqali (Ribociclib)
Kisqali 2022 sales: $1.231 billion
Company/Developer: Novartis
Date of first FDA approval: March 13, 2017
Indications Kisqali is FDA-approved for: Kisqali was approved for use with an aromatase inhibitor to treat HR-positive, HER2-negative breast cancer in post-menopausal women whose cancer is advanced or has spread to other parts of the body.
Price of Kisqali: The list price of Kisqali tablets is $6,064 to $15,162 per month, based on the dose.
Why it did so well: In January 2023, the USA National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) released an update recommending Kisqali as the only Category 1 Preferred CKD4/6 inhibitor for first-line treatment of patients with HR-positive/HER2-negative advanced breast cancer in combination with an aromatase inhibitor. Additionally, Kisqali has the highest rating of any CDK4/6 inhibitor on the ESMO Magnitude of Clinical Benefit Scale, achieving a score of five out of five for first-line pre-menopausal patients with HR-positive/HER2-negative advanced breast cancer. Further, Kisqali, in combination with either letrozole or fulvestrant, has uniquely, among other CDK4/6 inhibitors, received a score of four out of five for post-menopausal patients with HR-positive/HER2-negative advanced breast cancer treated in the first line.
For Kisqali, sales reached $1.5 billion for the first three quarters of 2023. Novartis attributed the growth to increased recognition of the drug’s life-extension benefit in metastatic breast cancer. Moreover, the positive results from the Phase III trial NATALEE analysis bolstered its efficacy and built confidence in the drug.
33. Yescarta (Axicabtagene Ciloleucel)
Yescarta 2022 sales: $1.160 billion
Company/Developer: Kite Pharma (Gilead Sciences)
Date of first FDA approval: October 18, 2017
Indications Yescarta is FDA-approved for: Yescarta is a CD19-directed genetically modified autologous T-cell immunotherapy (CAR T-cell therapy) used to treat large B-cell lymphoma and follicular lymphoma.
Price of Yescarta: Yescarta costs approximately $373,000 per treatment regimen.
Why it did so well: Yescarta surpassed the $1 billion mark in global sales due to higher demand in relapsed or refractory large B-cell lymphoma. In June, Kite announced detailed results from the overall survival analysis of the landmark Phase III ZUMA-7 study of Yescarta CAR T-cell therapy compared with the historical standard of care as initial treatment in the curative setting for patients with relapsed or refractory large B-cell lymphoma. Notably, Yescarta represents the first therapeutic intervention in nearly three decades to showcase a substantial enhancement in survival outcomes for this patient cohort.
34. Enhertu (Trastuzumab Deruxtecan)
Enhertu 2022 sales: $1.096 billion
Company/Developer: Daiichi Sankyo and AstraZeneca
Date of first FDA approval: December 20, 2019
Indications Enhertu is FDA-approved for: Enhertu is a targeted therapy that works against unresectable (not removable with surgery) and metastatic HER2-positive breast cancer that has been treated with an anti-HER2 medicine, as well as HER2-low breast cancer that has been treated with chemotherapy. Outside breast cancer, Enhertu became the first drug specifically approved for HER2-mutant NSCLC in August 2022.
Price of Enhertu: The cost for Enhertu intravenous powder for injection (nxki 100 mg) is around $2,855 for a supply of one powder for injection.
Why it did so well: As the primary ADC in Daiichi Sankyo’s oncology portfolio and the most advanced program within AstraZeneca’s ADC scientific platform, Enhertu holds a prominent position. AstraZeneca recorded sales of Enhertu amounting to $104 million in the initial half of 2023, while the alliance revenue generated for the drug reached $475 million.
35. Inlyta (Axitinib)
Inlyta 2022 sales: $1.003 billion
Company/Developer: Pfizer
Date of first FDA approval: January 27, 2012
Indications Inlyta is FDA approved for: Inlyta, in combination with pembrolizumab, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Inlyta as a single agent is indicated for treating advanced RCC after one prior systemic therapy fails.
Price of Inlyta: The cost of Inlyta oral tablet (1 mg) is around $21,644 for a supply of 180 tablets.
Why it did so well: Inlyta generated slightly more than $1 billion in sales in the first three quarters of 2023, which is mainly attributed to the adoption of combinations of certain immune checkpoint inhibitors and Inlyta for the first-line treatment of patients with advanced RCC. Moreover, it is protected by patent till 2025, which adds an edge to its revenue performance, making it safe from biosimilar competition.
36. Cyramza (Ramucirumab)
Cyramza 2022 sales: $971 million
Company/Developer: Eli Lilly and Company
Date of first FDA approval: April 21, 2014
Indications Cyramza is FDA approved for: Cyramza is used to treat stomach cancer, colorectal cancer, NSCLC that has spread to other parts of the body and hepatocellular carcinoma. Ramucirumab may be given alone or in combination with other cancer medicines. Cyramza is usually given after other cancer medicines have been tried without success.
Price of Cyramza: The list price of Cyramza is $15,234.45 to $17,138.76 per month.
Why it did so well: Due to its combinations with other cancer drugs for the treatment of multiple cancer types and patent protection till 2026, Cyramza remained one of the top revenue generators for Eli Lilly in 2023, with $721.1 million in revenue by the third quarter of 2023.
37. Alimta (Pemetrexed)
Alimta 2022 sales: $927 million
Company/Developer: Eli Lilly and Company
Date of first FDA approval: February 4, 2004
Indications Alimta is FDA-approved for: Alimta injection is used in combination with other chemotherapy medications as a first treatment for a certain type of NSCLC that has spread to nearby tissues or to other parts of the body. It is also indicated to treat malignant pleural mesothelioma.
Price of Alimta: The cost of Alimta (intravenous powder for injection, 100 mg) is around $861 for a supply of one powder for injection.
Why it did so well: Alimta held the most promise for extending mesothelioma life expectancy, due to which it was among the best-selling drugs by Eli Lilly for years. For the first three quarters of 2023, worldwide Alimta revenue was $172.6 million, a significant decrease compared to the $691.1 million the drug made during the same time in 2022. Alimta was shielded by exclusivity in the US until 2022, after which it faced fierce competition from generic drugs.
38. Zoladex (Goserelin Acetate)
Zoladex 2022 sales: $927 million
Company/Developer: Tersera in US and Canada; AstraZeneca worldwide
Date of first FDA approval: December 29, 1989
Indications Zoladex is FDA-approved to for: Zoladex implants are used to treat symptoms of prostate cancer in men. The Zoladex implant is also used in women to treat breast cancer or endometriosis. Zoladex is also used in women to prepare the lining of the uterus for endometrial ablation (a surgery to correct abnormal uterine bleeding). Zoladex is an artificial form of a hormone that regulates many processes in the body. Goserelin overstimulates the body’s own production of certain hormones, which causes that production to shut down temporarily.
Price of Zoladex: The cost of Zoladex (subcutaneous 3.6 mg implant) is around $1,006.
Why it did so well: The total sales of Zoladex in 2022 were $927 million. One of the prime reasons for the sales of Zoladex is that it is only available as brand-name medication, and no generic form is available.
39. Mvasi (Bevacizumab-awwb)
Mvasi 2022 sales: $901 million
Company/Developer: Amgen
Date of first FDA approval: September 14, 2017
Indications Mvasi is FDA-approved for: Mvasi is an anti-vascular endothelial growth factor A (anti-VEGF) monoclonal antibody biosimilar to Avastin for the treatment of multiple types of cancer, including metastatic colorectal cancer; NSCLC; glioblastoma; metastatic renal cell carcinoma; cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Price of Mvasi: The cost for Mvasi intravenous solution (awwb 25 mg/mL) is around $744 for a supply of 4 mL.
Why it did so well: Rising cancer incidence is a major factor propelling the growth of bevacizumab biosimilars like Mvasi. Despite stiff competition, Mvasi sales increased two percent year-over-year for the third quarter of 2023.
40. Vectibix (Panitumumab)
Vectibix 2022 sales: $893 million
Company/Developer: Amgen
Date of first FDA approval: September 27, 2006
Indications Vectibix is FDA-approved for: Vectibix is the first fully human monoclonal anti-EGFR antibody antagonist indicated for the treatment of metastatic colorectal cancer (mCRC). In May 2014, the FDA approved Vectibix for use in combination with FOLFOX, as first-line treatment in patients with wild-type KRAS (exon 2) mCRC. With this approval, Vectibix became the first and only biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens, in the first-line treatment of mCRC for patients with wild-type KRAS mCRC.
Price of Vectibix: The cost for Vectibix intravenous solution (20 mg/mL) is around $1,745 for a supply of 5 mL.
Why it did so well: Vectibix experienced a two percent sales increase in 2022, bringing in $893 million; for Q2 2023, its sales increased 20 percent year-over-year to $248 million. According to Amgen, the 20 percent volume growth was supported by the promotion of positive data from the company’s Phase III PARADIGM trial, demonstrating the superiority of Vectibix over bevacizumab in combination with chemotherapy. The absence of any biosimilars has also helped Vectibix maintain its year-over-year growth in revenue.
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