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FDA Approves Myriad CDx With AstraZeneca Drug for BRCA-Mutated Breast Cancer Patients

NEW YORK (GenomeWeb) – The US Food and Drug Administration today expanded the indication for AstraZeneca's PARP inhibitor Lynparza (olaparib) for metastatic breast cancer patients who have BRCA-mutated tumors.

Simultaneously, the agency also expanded the indication for Myriad Genetics' BRACAnalysis CDx as a test that can identify which breast cancer patients have germline BRCA mutations and therefore are most likely to benefit from Lynparza.

The FDA's priority approval for the drug was based on a trial evaluating the safety and efficacy of drug in around 300 patients with HER2-negative, BRCA-mutated metastatic breast cancer receiving Lynparza or chemotherapy. Patients on the Lynparza arm had a median progression-free survival of 7 months compared to 4.2 months for those only receiving chemo. Severe side effects of Lynparza on the trial were blood or bone marrow cancers and pneumonitis. 

This is not only the first PARP inhibitor to be approved for breast cancer, but the first personalized treatment option specifically for BRCA-mutated breast cancer patients.

"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, 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 a cancer, often across cancer types."

According to the National Cancer Institute, around 253,000 women will be diagnosed with breast cancer this year and nearly 41,000 will die of the disease. BRCA mutations show up in up to 25 percent of patients with hereditary breast cancers and between 5 percent and 10 percent of the overall breast cancer population.

Previously, the agency approved Lynparza for the treatment of patients with BRCA-mutated, advanced ovarian cancer who have received three or more treatments of chemotherapy, and for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have responded to chemo. BRACAnalysis CDx is an FDA-approved test for identifying best responders to Lynparza when used in the fourth-line ovarian cancer setting, but in the maintenance setting, the drug is approved regardless of BRCA mutation status. 

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