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FDA Approves Myriad Genetics BRCA CDx With Pfizer's Metastatic Breast Cancer Drug

NEW YORK (GenomeWeb) – The US Food and Drug Administration has approved Myriad Genetics' BRACAnalysis CDx for determining which HER2-negative, metastatic breast cancer patients have inherited BRCA1 and BRCA2 genetic mutations and therefore may benefit from treatment with Pfizer's Talzenna (talazoparib).

The companion diagnostic approval accompanied the regulatory approval of Pfizer's PARP inhibitor Talzenna. Talzenna is indicated as a treatment for advanced or metastatic breast cancer patients who have BRCA mutations as determined by an FDA-approved companion diagnostic.

In order to approve the drug and the test, the FDA considered data from the EMBRACA trial involving more than 400 advanced breast cancer patients with BRCA mutations who were tested with BRACAnalysis CDx. The study showed that Talzenna-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. 

Myriad announced in June that it had submitted a supplementary premarket review application for BRACAnalysis CDx so that it may be used to identify best responders to Talzenna. 

Pfizer is also investigating Talzenna as a neoadjuvant treatment for triple-negative breast cancer patients with BRCA mutations. Myriad announced last week it had signed a new lab services agreement with Pfizer to provide BRACAnalysis CDx testing within a Phase II study evaluating Talzenna in this setting. 

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.


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