US approves first drug aimed at women with inherited breast cancer

WASHINGTON — The Food and Drug Administration on Friday cleared the first treatment for patients with advanced breast cancer caused by BRCA mutations, which are genetic defects that raise the risk of malignancies.

The drug, called Lynparza, already is approved for certain patients with advanced ovarian cancer associated with the same mutations.

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said expanding the approval to breast-cancer patients ‘‘demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types.’’


Lynparza belongs to a class of drugs called PARP inhibitors that block an enzyme involved in repairing damaged DNA. By blocking the enzyme, the DNA in cancer cells may be less likely to be fixed, leading to the death of those cells and potentially a slowdown or halt in tumor growth, the FDA said.

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The drug, also known as olaparib, is marketed by AstraZeneca and Merck.

The agency said its approval was based on a randomized clinical trial of 300 advanced breast cancer patients with BRCA 1 or BRCA 2 mutations.

The trial found that the length of time during which the tumors did not grow significantly, called progression-free survival, was a median of 7 months for patients treated with Lynparza compared with 4.2 months for patients receiving chemotherapy only.