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FDA Accepts Myriad BRACAnalysis CDx Supplementary PMA for Lynparza in Breast Cancer Indication

NEW YORK (GenomeWeb) – The US Food and Drug Administration has accepted Myriad Genetics' supplementary premarket approval application for BRACAnalysis CDx as a test that may be used to identify metastatic breast cancer patients who are most likely to respond to AstraZeneca's Lynparza (olaparib).

The Phase III OlympiAD trial, published in the New England Journal of Medicine this summer, found that Lynparza reduced the risk of disease progression in patients with BRCA-mutated, HER2-negative metastatic breast cancer by 42 percent compared to standard therapy. The study participants had to have inherited deleterious or likely deleterious BRCA mutations as determined by BRACAnalysis CDx.

The agency has granted the drug and test priority review, which the molecular diagnostic firm expects to conclude during its fiscal third-quarter, which ends March 31, 2018.

Several years ago, the FDA approved Lynparza for patients with germline BRCA-mutated advanced ovarian cancer, who have received three or more prior lines of chemotherapy. At that time, the FDA also approved BRACAnalysis CDx to identify patients with germline mutations who are most likely to respond to the drug. 

"The acceptance of the sPMA for BRACAnalysis CDx is a significant step towards enabling personalized medicine for patients with metastatic breast cancer," Myriad CEO Mark Capone said in a statement. Myriad estimated that around 125,000 metastatic breast cancer patients would immediately qualify for testing with its companion diagnostic and 60,000 new patients each year after.

Analyst Doug Schenkel wrote in a note to investors that assuming an average selling price of around $2,000, the addressable market opportunity for testing survivors is around $250 million, while the total addressable market opportunity for testing newly diagnosed patients is approximately $120 million annually.

In Wednesday morning trade on the Nasdaq, shares of Myriad were down around 3 percent at $24.61.