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Myriad Genetics Submits Supplementary PMA for BRACAnalysis CDx

NEW YORK (GenomeWeb) – Myriad Genetics has submitted a supplementary premarket approval application for its BRACAnalysis CDx test to the US Food and Drug Administration, so that it can be used to identify best responders to Pfizer's PARP inhibitor talazoparib.

Talazoparib has priority review status from the FDA and the agency is expected to issue a decision by December. Myriad and Pfizer have submitted data to the FDA from the EMBRACA trial, which involved more than 400 HER2-negative advanced breast cancer patients who had germline BRCA mutations as defined by BRACAnalysis CDx. 

In December, researchers presented data from this study showing that talazoparib-treated patients had a median progression-free survival of 8.6 months compared to 5.6 months for those receiving their physician’s choice of treatment with capecitabine, eribulin, gemcitabine, or vinorelbine. 

At the time these data were presented, interim median overall survival with 51 percent projected events was 22.3 months in the talazoparib arm versus 19.5 months in the chemotherapy arm. This was not a statistically significant finding, but researchers noted that there will be further follow-up to obtain final overall survival data.

The FDA previously approved Myriad's BRCA test as a companion diagnostic for AstraZeneca's PARP inhibitor Lynparza (olaparib) when used as a maintenance therapy for platinum-sensitive ovarian cancer; and as a complementary diagnostic for Tesaro's Zejula (niraparib), when used as a maintenance treatment for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Myriad is also working with Clovis Oncology to use BRACAnalysis CDx to identify best responders to its third-line advanced ovarian cancer drug Rubraca (Rucaparib) as part of a post-marketing commitment for the drug.