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Myriad Genetics to Seek BRCA CDx Approval From Japanese Regulators

NEW YORK (GenomeWeb) – Myriad Genetics said today that it will submit its BRACAnalysis CDx to Japan's Pharmaceuticals and Medical Devices Agency for regulatory approval, alongside AstraZeneca's PARP inhibitor Lynparza (olaparib).

In December 2014, the US Food and Drug Administration approved BRACAnalysis CDx as a test for identifying advanced ovarian cancer patients previously treated with three or more lines of chemotherapy, who harbor mutations in BRCA1 and BRCA2 genes and therefore might benefit from treatment with Lynparza.

Earlier this year, the FDA also granted fast track designation to Lynparza as a treatment for BRCA-mutated, platinum-sensitive, relapsed ovarian cancer. AstraZeneca recently announced that the Phase III SOLO-2 trial had shown that this subset of ovarian cancer patients experienced statistically-significant improvement in progression-free survival when they received Lynparza as a second-line maintenance treatment compared to those who received placebo. The drugmaker is planning to announce full results from SOLO-2 at an upcoming medical meeting.

At a Drug Information Association meeting a year ago, the companies provided a look at their development process for the companion diagnostic, noting that the process of getting it approved could provide a blueprint for other companies looking to take laboratory-developed tests through the FDA.

In June, AstraZeneca also announced a partnership with Foundation Medicine to develop a next-generation sequencing based CDx as part of its global development program for Lynparza.