Authorization

Myriad Submits sPMA for BRACAnalysis CDx as a Companion Diagnostic for Lynparza in Metastatic Castration-resistant Prostate Cancer

SALT LAKE CITY, Jan. 21, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced today that it has submitted a supplementary premarket approval (sPMA) application to the U.S. Food and Drug Administration (FDA) for its BRACAnalysisA CDx test as a companion diagnostic to AstraZenecaa??s (LSE/OMX Nordic/NYSE: AZN) and Mercka??s PARP inhibitor LynparzaA (olaparib) for men with metastatic castration-resistant prostate cancer.A
a??This submission represents our tenth PMA filing for BRACAnalysis CDx in support of Lynparza and will help men with metastatic castration-resistant prostate cancer get access to the most advanced therapies,a?? said Nicole Lambert, president Myriad Oncology. a??Myriad remains highly committed to helping our pharmaceutical partners deliver precision medicine for patients with cancer.a??
Myriada??s filing for BRACAnalysis CDx is based on the positive clinical results from the PROfound study, which assessed the efficacy and safety of olaparib versus abiraterone acetate or enzalutamide in men with metastatic castration-resistant prostate cancer who have progressed on prior treatment with new hormonal agent treatments and have a mutation in their homologous recombination repair (HRRm) genes. The trial met its primary endpoint demonstrating a statistically-significant and clinically-meaningful improvement of radiographic progression-free survival (rPFS) among men with mutations inABRCA1/2AorAATMAwho were treated withAolaparib. The trial also met a key secondary endpoint demonstrating significant rPFS with olaparib in the overall trial population of men with BRCA1/2, ATM, CDK12 and 11 other HRRm gene mutations.
Every year approximately 32,000 men are diagnosed with, or progress to, metastatic prostate cancer in the United States.A
The collaboration between Myriad and AstraZeneca began in 2007 and has resulted in multiple regulatory approvals for BRACAnalysis CDx enabling more patients to benefit from treatment with olaparib.
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