FDA OKs Myriad's BRACAnalysis CDx Test As Companion Diagnostics For Lynparza

Molecular diagnostics company Myriad Genetics, Inc. (MYGN) announced Wednesday that the U.S. Food and Drug Administration (FDA) approved its BRACAnalysis CDx test for use as a companion diagnostic by healthcare professionals to identify men with metastatic castration-resistant prostate cancer (mCRPC) who are eligible for treatment with Lynparza (olaparib).

BRACAnalysis CDx is the only FDA-approved germline test to identify men with BRCA1 and BRCA2 mutations, a subpopulation of homologous recombination repair (HRR) gene mutations.

This approval is Myriad Genetics' seventh regulatory approval for BRACAnalysis CDx in support of Lynparza and further demonstrates its commitment to improve the lives of patients with cancer.

The approval was based on the PROfound trial in which patients with metastatic castration-resistant prostate cancer who have HRR gene mutations had a statistically-significant and clinically meaningful improvement of radiographic progression-free survival when treated with Lynparza versus abiraterone acetate or enzalutamide.

Lynparza is approved for the treatment of adult patients with deleterious or suspected deleterious germline or somatic HRR gene-mutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone.

Lynparza is a novel PARP inhibitor jointly developed and commercialized by AstraZeneca (AZN) and Merck, known as MSD outside of the U.S. and Canada.

Prostate cancer is the second-most common cancer in men and is associated with a significant mortality rate. In men with mCRPC, their prostate cancer grows and spreads to other parts of the body despite the use of androgen-deprivation therapy to block the action of male sex hormones.

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