AstraZeneca and Merck’s Ovarian Cancer Drug Gets Expanded Indication for Specific BRCA Mutation

Update (May 9, 2018): AstraZeneca’s Lynparza has been approved by Health Canada for the treatment of patients with ovarian cancer, regardless of whether they carry a BRCA mutation. While the same approval has been granted by the EMA, the FDA currently still requires that patients treated with the PARP inhibitor have a confirmed BRCA mutation.

Originally published on January 16, 2018:

AstraZeneca and Merck’s Lynparza has become the first drug to be approved to treat breast cancer patients with a confirmed BRCA mutation. The drug was approved in 2014 to treat ovarian cancer, but has now become the first PARP inhibitor to be approved for a breast cancer indication.

“This class of drugs has been used to treat advanced, BRCA-mutated ovarian cancer and has now shown efficacy in treating certain types of BRCA-mutated breast cancer,” said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types.”

Lynparza works by preventing an enzyme involved in repairing damaged DNA from performing its function. In this way, the drug inhibits repair of BRCA gene mutations inside cancerous cells, potentially promoting cell death and slowing tumor growth.

According to AstraZeneca, Lynparza has a list price of $13,886 per month of treatment, however insured patients will likely pay less. The pharma company has also announced they’ll be offering financial assistance to select patients.

“Patients diagnosed with BRCA-related metastatic breast cancer are often younger than other breast cancer patients, and their disease is often much more aggressive and difficult to treat,” said Dr. Susan M. Domchek, Executive Director of the Basser Center for BRCA at the Abramson Cancer Center of the University of Pennsylvania. “While there is currently no cure for metastatic breast cancer, today’s approval offers a new targeted option that may help to delay disease progression for these patients.”

The BRACAnalysis CDx has also received an expanded indication from the FDA to identify breast cancer patients with a BRCA mutation. The approval is a boon for Myriad Genetic Laboratories, the company that developed the BRACAnalysis CDx, as it is the only companion diagnostic approved for this indication.

“We congratulate AstraZeneca and Merck on obtaining FDA approval of Lynparza for patients with metastatic breast cancer, which is the first approval of a PARP inhibitor outside of ovarian cancer.  As the pioneers in identifying likely responders to PARP inhibitors, we are excited to broaden the use of BRACAnalysis CDx as the companion diagnostic for this important new indication,” said Mark C. Capone, president and CEO, Myriad Genetics.  “We will be actively working with all stakeholders to raise awareness so that patients can be immediately tested to determine if they are likely to benefit from Lynparza.”

Over 250,000 women are predicted to be diagnosed with breast cancer in 2018, and over 40,000 patients are expected to die as a result. The incidence of BRCA mutations is up to 25 percent in patients with hereditary breast cancer and between five and ten percent for other forms of the disease.