FDA Approves Lynparza to Treat BRCA-mutated Metastatic Breast Cancer

FDA Approves Lynparza to Treat BRCA-mutated Metastatic Breast Cancer
The U.S. Food and Drug Administration (FDA) has approved Lynparza (olaparib) for a difficult-to-treat form of metastatic breast cancer. Patients with BRCA-mutated, HER2-negative breast cancer who have previously been treated with chemotherapy are now approved to be treated with Lynparza. The FDA's approval is based on data showing that Lynparza — developed by AstraZeneca working together with Merck (known as MSD outside the U.S. and Canada) — prolonged the time patients lived without their cancer progressing, compared to standard-of-care chemotherapy. "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," Roy Baynes, senior vice president and head of Global Clinical Development, and chief medical officer at Merck, said in a press release. Lynparza was initially approved by the FDA for the treatment of BRCA-mutated advanced ovarian cancer in December 2014. In August 2017, the regulatory agency extended its approval to include the maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer. Lynparza is a PARP inhibitor, which acts to block DNA repair processes. The PARP enzyme is particularly important for DNA repair in people with BRCA mutations, and blocking it prevents the survival of tumors. "This new approval for Lynparza makes it the fi
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