FDA concurrent approval of BRACAnalysis CDx and olaparib
“On December 19, 2014, the FDA approved olaparib capsules (Lynparza; AstraZeneca) for the treatment of patients with deleterious or suspected deleterious germline BRCAmutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. The BRACAnalysis CDx (Myriad Genetic Laboratories, Inc.) was approved concurrently.”
Kim G, et al. FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious GermlineBRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy. Clinical Cancer Research 2015.
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