The US Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ Rolvedon (eflapegrastim-xnst) injection.
Rolvedon is a leukocyte growth factor administered to help prevent infection due to chemotherapy-induced neutropenia.
Rolvedon is indicated to lower the chance of infection from febrile neutropenia (the development of fever, often with other signs of infection, in patients with a very low number of neutrophil granulocytes in the blood) in adult patients with non-myeloid malignancies on myelosuppressive anti-cancer drugs.
Myelosuppressive drugs kill cancer cells and normal cells in the bone marrow, which diminishes the amount of normal red blood cells, white blood cells and platelets in the bone marrow and blood. The common side effects of myelosuppressive drugs include fatigue, anemia and tachycardia. Additionally, myelosuppressive drugs may lead to serious side effects such as febrile neutropenia.
Febrile neutropenia, also known as neutropenic fever, is a common and severe side effect of myelosuppressive drug therapy in cancer patients. Febrile neutropenia is a common complication in cancer patients with low neutrophil counts, impacting 10 to 50 percent of those with solid malignancies and 80 percent of those with hematological malignancies.
“Rolvedon’s approval marks Spectrum’s transformation to a commercial-stage company with the opportunity to compete in a $2 billion dollar market, and offers a unique value proposition,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals, in the company’s press release.
Rolvedon was developed with the help of South Korean Hanmi Pharmaceuticals’ proprietary Laspscovery platform (Long Acting Protein/Peptide Discovery Platform Technology). This new technology extends the half-life of biologics and can thus substantially lower the dose amount and number of doses.
“This approval is a significant milestone for our development team and collaboration with Hanmi Pharmaceutical. On behalf of Spectrum, I would like to thank all of the patients, families, health care providers, and our own team members for bringing this goal to fruition,” added Riga.
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How Does Rolvedon Work?
Rolvedon is the first long-acting granulocyte colony-stimulating factor (GCSF) to be FDA-approved in over 20 years that is not a biosimilar. Rolvedon is a new formulation that is produced by covalent coupling of a human G-CSF analog and an Fc fragment of human immunoglobulin G4 (IgG4), both made from recombinant E. coli.
Rolvedon works by binding to G-CSF receptors of myeloid progenitor cells and neutrophils. The binding triggers cell differentiation, proliferation, migration and survival. This way, Rolvedon elevates the neutrophil count in cancer patients.
Rolvedon is administered subcutaneously around 24 hours after cytotoxic chemotherapy, once per chemotherapy cycle.
Clinical Trials and Commercialization
Two identically designed Phase III clinical trials, ADVANCE and RECOVER, assessed the safety and efficacy of Roveldon in a total of 643 early-stage breast cancer patients for the management of neutropenia from myelosuppressive chemotherapy.
The clinical trials were randomized, open label, noninferiority clinical trials. A non-inferiority trial is designed to show that a novel treatment is not unacceptably less efficacious than the current standard therapy.
In both studies, patients were affected by non-myeloid malignancies and were receiving myelosuppressive anti-cancer drugs intravenously every 21 days (docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2) for four cycles. The subcutaneous administration of eflapegrastim or the standard-of-care pegfilgrastim was done by Day 2 after chemotherapy. The efficiency of eflapegrastim was based on the duration of severe neutropenia.
Across all four cycles of chemotherapy in both clinical studies, Rolvedon had a similar safety profile to pegfilgrastim and was shown to be non-inferior to pegfilgrastim in the mean duration of severe neutropenia.
“Our commercial team is in place and ready to engage key stakeholders immediately,” said Erin Miller, Senior Vice President, Sales and Marketing of Spectrum Pharmaceuticals.
“Equipped with extensive long-acting growth factor market experience, customer connectivity and learnings from in-depth market research insights, we are ready to optimize the launch trajectory. We expect to have product available in the fourth quarter of 2022 following the fulfillment of customary, pre-launch regulatory requirements,” added Miller.