FDA Approval Order

December 19, 2014

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FDA Labeling

Technical Information Summary

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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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BRACAnalysis CDx as a companion diagnostic tool for Lynparza

“Lynparza and its companion diagnostic test, BRACAnalysis were approved by the US FDA in December 2014 for recurrent ovarian cancer in women with a germline BRCA mutation. Women with a deleterious BRCA mutation are predisposed to ovarian cancer due to deficient homologous recombination repair. Inhibition of the PARP enzyme forces use of an alternate error-prone pathway for repair; PARP trapping is another mechanism utilized that blocks cellular replication by trapping inactivated PARP onto single-stranded DNA breaks. Although many companion diagnostic kits are already in use in oncology, BRACAnaylsis is unique in several ways including comprehensive BRCA gene germline profiling, availability to all women with ovarian cancer and implications for family members.”

Gunderson CC, et al. BRACAnalysis CDx as a companion diagnostic tool for Lynparza. Expert Rev. Mol. Diagn. 2015.

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