The Food and Drug Administration approved AstraZeneca PLC’s Lynparza for patients with inherited BRCA gene mutations who have undergone chemotherapy, the FDA said in a statement. The approval was announced on Friday.
The drug has been on the market since 2014 for ovarian cancer, and recently has been approved to treat breast cancer. It is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a BRCA gene mutation.
“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.”
Approximately 20 percent to 25 percent of patients with hereditary breast cancers and up to 10 percent of patients with any type of breast cancer have a BRCA mutation. BRCA genes are involved with repairing damaged DNA and normally work to prevent tumor development. However, mutations of these genes may lead to certain cancers, including breast cancers, the FDA statement said.
The fast-tracked approval of Lynparza was based on a trial of 302 women with metastatic breast cancer and a BRCA gene mutation. The drug delayed the spread of the cancer for seven months as opposed to four months for women taking chemotherapy only, according to the FDA.
Lynparza will cost $13,886 per month without insurance, the Associated Press reported, citing AstraZeneca.