Myriad Genetics has signed on to a commercialization plan with Pfizer, expanding and cementing their companion diagnostic agreement for the company’s BRACAnalysis CDx test.
Myriad’s BRACAnalysis in vitro test is currently under FDA review alongside the Big Pharma’s PARP inhibitor talazoparib, for patients with HER2-negative locally advanced or metastatic breast cancer with inherited BRCA mutations.
Under the commercialization plan, each company will remain responsible for its respective products, though the companies will collaborate on certain activities promoting the use of the test, they said.
Myriad expects a decision from the FDA by the end of the year. Its BRACAnalysis CDx test has already been approved as a companion diagnostic for talazoparib’s potential PARP competitors, AstraZeneca and Merck’s breast cancer drug Lynparza, as well as Tesaro’s Zejula in ovarian cancer.
The DNA-based blood test detects variants in the protein-coding regions and boundaries of the BRCA1 and BRCA2 genes, and is performed only at Myriad’s laboratories in Salt Lake City, Utah. BRCA mutations are implicated in more than 25% of inherited breast cancers and between 5% and 10% of all incidences of the disease, Pfizer has said, and performing genetic testing at diagnosis could potentially become the norm.
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The two companies’ new drug application and supplementary premarket approval submissions were based on a phase 3 trial of 431 patients comparing talazoparib to a physician’s choice of chemotherapy.
Late last year, Pfizer revealed that patients taking the PARP inhibitor had a 46% reduction in the risk of cancer progression compared to those treated with chemotherapy, with progression-free survival benefits seen across several subgroups of patients, including in triple-negative breast cancer.