FDA approves first drug for breast cancer with BRCA gene

FDA approved the first drug to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation.

FDA expanded the approved use of olaparib (Lynparza, AstraZeneca and Merck) beyond ovarian cancer, to include the treatment of patients with certain types of breast cancer that have metastasized and whose tumors have a specific inherited BRCA genetic mutation

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Lynparza is also the first drug in its class (PARP inhibitor) approved to treat breast cancer.

“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 Richard Pazdur, MD, director of 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, in a statement from FDA. “This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types.”

“This additional approval for Lynparza represents an important advance for women with HER2-negative metastatic breast cancer with a germline BRCA mutation, which is a difficult-to-treat cancer,” said Roy Baynes, senior vice president and head of Global Clinical Development and chief medical officer at Merck Research Laboratories, in a statement from AstraZeneca and Merck.

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FDA also expanded the approval of the BRACAnalysis CDx (Myriad Genetic Laboratories) test, an approved companion diagnostic to Lynparza, to include the detection of BRCA mutations in blood samples from patients with breast cancer.

The safety and efficacy of Lynparza to treat breast cancer was based on a randomized clinical trial of 302 patients with HER2-negative metastatic breast cancer with a germline BRCA mutation. The median progression-free survival for patients taking Lynparza was 7 months, compared to 4.2 months for patients receiving chemotherapy only.

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