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FDA OKs Lynparza to Treat Breast Cancer With BRCA Mutation

FRIDAY, Jan. 12, 2018 -- Lynparza (olaparib) has been approved by the U.S. Food and Drug Administration to treat metastatic breast cancer caused by a BRCA gene mutation.

Lynparza, a poly ADP-ribose polymerase (PARP) inhibitor, was evaluated to treat breast cancer in clinical studies involving 302 participants. Patients who took the drug had an average seven months of progression-free survival, compared to 4.2 months among patients who were given only chemotherapy.

Lynparza's most common side effects included anemia, neutropenia, leukopenia, nausea, fatigue, vomiting, cold-like symptoms, and respiratory tract infections. More serious adverse reactions could include development of myelodysplastic syndrome/acute myeloid leukemia and pneumonitis, the FDA said. The drug shouldn't be taken by women who are pregnant, hoping to become pregnant, or breast-feeding, the agency warned.

"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," Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence, said in a statement. "This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of cancer, often across cancer types."

Lynparza is produced by the British drug maker AstraZeneca, whose U.S. headquarters are in Wilmington, Del.

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Posted: January 2018