Myriad Genetics Files for FDA Approval of BRAC Analysis CDx for Lynparza in Prostate Cancer

Myriad Genetics has submitted a supplementary premarket approval application with the US Food and Drug Administration for its BRACAnalysis CDx to identify metastatic castration-resistant prostate cancer patients with germline BRCA1/2 mutations, who may respond well to Merck’s olaparib (Lynparza).

Also today, AstraZeneca and Merck also announced that the FDA has accepted their supplemental new drug application for olaparib as an option for metastatic castration-resistant prostate cancer patients who have progressed on a new hormonal agent, and have deleterious or suspected deleterious mutations in more than a dozen genes involved in homologous recombination repair, including BRCA1/2.

The latest submissions for Myriad’s BRCA test and olaparib include data from the randomized, Phase III PROfound study, which compared olaparib against new hormonal agents in metastatic castration-resistant prostate cancer patients who had a mutation in one of 15 HRR genes. The primary endpoint was to assess radiographic progression-free survival in patients with BRCA1/2 or ATM genetic mutations. If patients in this cohort showed a clinical benefit, then an analysis would be done to gauge olaparib’s efficacy in the overall population with mutations in the other HRR genes.

Source: https://www.genomeweb.com/cancer/myriad-genetics-files-fda-approval-bracanalysis-cdx-lynparza-prostate-cancer