New FDA Approvals: The FDA Granted an Additional Indication to Lynparza

March 11: The FDA granted an additional indication to AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) for the treatment of people with germline BRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with chemotherapy before or after surgery. The agency first approved the tablet on Dec. 19, 2014. Dosing is 300 mg twice daily. Website Drugs.com lists the price of 60 150 mg tablets as more than $7,778.

March 11: The FDA approved another use for Myriad Genetics, Inc.’s BRACAnalysis CDx test as a companion diagnostic to identify people with germline BRCA-mutated HER2-negative, high-risk early-stage breast cancer who may benefit from Lynparza (see above brief). The test detects and interprets germline BRCA1 and BRCA2 variants. The agency initially approved the test on Dec. 19, 2014.

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