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

NEW YORK – Myriad Genetics said today that it 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 others HRR genes.

In the PROfound study, the drugmakers collaborated with Myriad to identify patients with germline BRCA1/2 mutations, and with Foundation Medicine, which markets the next-generation sequencing multi-gene test FoundationOne CDx.

Researchers presented data from this study last year at the European Society for Medical Oncology. They reported that olaparib significantly reduced radiographic progression or death by 66 percent in patients with BRCA1/2 or ATM gene mutations. Patients with these mutations had a median radiographic progression-free survival of 7.4 months versus 3.6 months for those receiving abiraterone or enzalutamide. In the overall population of patients with mutations in all the HRR genes of interest, patients on olaparib had a median radiographic progression-free survival of 5.8 months versus 3.5 months on the comparator arm.

The FDA is expected to issue a decision on AstraZeneca/Merck's olaparib application in the second quarter of this year. Last week, the agency also accepted Clovis Oncology's supplemental new drug application for recaparib (Rubraca) in metastatic castrate-resistant prostate cancers with BRCA1/2 mutations.