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Myriad Genetics Wins FDA SPMA Nod for BRACAnalysis CDx

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Myriad Genetics, Inc. MYGN has moved one step forward in acquiring the FDA approval for the company’s BRACAnalysis CDx test to be used as a companion diagnostic with Pfizer’s PFE PARP inhibitor, talazoparib. The company noted that the FDA has accepted its supplementary premarket approval (sPMA) application for BRACAnalysis CDx, which can help identifying the best responders to talazoparib.

It is also encouraging to know that talazoparib is currently holding the status of New Drug Application (NDA) priority review from the FDA with a target date set for December 2018.

Both Myriad Genetics and Pfizer submitted their respective sPMA and NDA proposals to the FDA, based on results from the Pfizer-sponsored EMBRACA trial, which evaluated talazoparib compared with chemotherapy in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC). 

Last December, the primary results of the study were presented. The data showed that patients with gBRCA+ locally advanced and/or metastatic breast cancer (MBC) demonstrated superior progression-free survival (PFS) when treated with talazoparib in comparison to those having received physician’s choice standard-of-care chemotherapy. 

Recent Developments in BRACAnalysis

Myriad Genetics has been leaving no stone unturned to boost the uptake of BRACAnalysis CDx. In this regard, the system got manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare, earlier in April this year. The system can now be used as a companion diagnostic with the PARP inhibitor, Lynparza.

Notably, in January, the FDA approved BRACAnalysis CDx test for usage as a companion diagnostic with AstraZeneca AZN and Merck’s MRK PARP inhibitor, Lynparza (olaparib) on patients with HER2-negative metastatic breast cancer (MBC) and germline BRCA mutation.

Market Potential

Per Myriad Genetics, about 40,000 patients with metastatic disease are currently eligible for BRACAnalysis testing in Japan. Moreover, approximately 15,000 new cases of HER2-negative breast cancer are diagnosed every year. This promising data indicates what a timely and strategic role the latest approval is likely to play in favor of the company.

Share Price Performance

 

 

Myriad Genetics has been gaining investors’ confidence from consistently positive results. Over the past three months, shares of the company have significantly outperformed the broader industry. The stock has surged 36.6% against the broader industry’s 5.2% fall.

Myriad Genetics currently carries a Zacks Rank #3 (Hold).

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