FDA Approves First Therapy for Breast Cancer With Specific Genetic Mutation


The US Food and Drug Administration (FDA) expanded the approved use of a therapy for metastasized breast cancer with a certain germline genetic mutation.

Olaparib (Lynparza, AstraZeneca) is now approved to treat patients with metastasized breast cancer and a BRCA mutation. This approval marks the first drug indicated to treat patients with a certain inherited genetic mutation.

The FDA first approved olaparib in 2014 to treat certain patients with ovarian cancer.

The safety and efficacy of olaparib for the treatment of breast cancer was based on a randomized clinical trial of 302 patients with human epidermal growth factor 2 (HER2)-negative metastatic breast cancer with a germline BRCA mutation. The median progression-free survival for patients receiving olaparib was 7 months compared to 4.2 months for those receiving chemotherapy alone.

“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 the FDA’s Oncology Center of Excellence, acting director of the Office of Hematology and Oncology Products, FDA’s Center for Drug Evaluation and Research, in a press release (January 12, 2018). “This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types.”


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The FDA also expanded the approval of the BRACAnalysis CDx—a diagnostic companion test to olaparib—to include the detection of BRCA mutations in blood samples from patients with breast cancer.—Zachary Bessette