Myriad Receives FDA SPMA Approval for BRACAnalysis CDx

- June 19th, 2018

Once approved, BRACAnalysis CDx will be used with Pfizer’s PARB inhibitor, talazoparib. Talazoparib has a prescription drug user fee act goal date of later this year.

Myriad Genetics (NASDAQ:MYGN) is getting closer to receiving full US Food and Drug Administration (FDA) approval for its BRACAnalysis CDx test, which will be used with Pfizer’s (NYSE:PFE) PARB inhibitor, talazoparib.

The company announced on Monday (June 18), that the FDA has accepted its application for the supplementary premarket approval for BRACAnalysis CDx, while the new drug application (NDA) for talazoparib has been granted priority review by the FDA. Talazoparib also has a prescription drug user fee act goal date of December 2018.

The release states that both companies’ NDA submissions are based on the results from Pfizer’s EMBRACA trial, which was completed in a study in December 2017. The study evaluated talazoparib against chemotherapy in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC).

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Mark Capone, president and CEO of Myriad said in the release that the FDA submission contributes to the company’s milestones in being able expanding access to this type of drug across different types of cancers.

“We are excited to pursue a simultaneous diagnostic approval along with talazoparib, as another outstanding opportunity to advance personalized medicine for oncology patients,” he added.

The company projects that there are roughly 125,000 people living with metastatic breast cancer that would qualify for the BRACAAnalysis CDx test with an additional 60,000 patients annually on an ongoing basis.

This isn’t the only notable milestone Myriad Genetics has received for BRACAnalysis CDx. In January the company received FDA approval of the product to be used as a companion diagnostic by healthcare professionals in order to identity patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are candidates for treatment with the PARP inhibitor Lynparza (olaparib) . The release said BRACAnalysis CDx is the first–and only at the time–FDA-approved test for use in this indication.

“Myriad’s BRACAnalysis CDx test was proven to accurately identify those patients who had a germline BRCA mutation and may benefit from Lynparza,” Johnathan Lancaster, chief medical officer of Myriad said in January’s release.

Myriad also announced a partnership with Clovis Oncology (NASDAQ:CLVS) in April 2017 for useof BRACAnalysis CDx to identify patients with germline BRCA mutations for Rubraca treatment. Rubraca was approved in December 2016 and is Clovis’ ovarian cancer treatment for women who have been treated with two or more chemotherapies and whose tumors have a BRCA mutation identified by an FDA-approved companion diagnostic test.

BRACAnalysis CDx is an FDA-approved laboratory developed test for BRCA1 and BRCA2, which is meant to inform patient management related to PARP inhibitors, Lynparza and Zejula.

Following Monday’s announcement, shares of Myriad Genetics have dipped 1.47 percent to US$39.58 as of 3:38 p.m., EST on Tuesday (June 19). TradingView.com technical analysis currently ranks the company as a “Buy” with 14 indicators in favor of the company, whereas two rank Myriad as a “Sell” with 10 at “Neutral.” Myriad has a 52-week share price high of US$41.57 and a low of US$23.28.

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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article. 

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