FDA has approved the BRACAnalysis CDx test for use as a companion diagnostic to identify men with metastatic castration-resistant prostate cancer who are eligible for treatment with Lynparza (olaparib).
Lynparza is approved for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with enzalutamide or abiraterone. Lynparza is a novel PARP inhibitor jointly developed and commercialized by AstraZeneca, and Merck outside of the U.S. and Canada.
“This approval is our seventh regulatory approval for BRACAnalysis CDx in support of Lynparza and further demonstrates our commitment to improve the lives of patients with cancer,”Nicole Lambert, president Myriad Oncology and Women’s Health, said in a statement.
BRACAnalysis CDx is the only FDA-approved germline test to identify men with BRCA1 and BRCA2 mutations, a subpopulation of HRR gene mutations. In the PROfound trial, 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.
“Studies have demonstrated that PARP inhibitors are highly effective in men with BRCA1/BRCA2 mutations, in addition to other mutations in HRR pathways. Once we identify who these men are, they will have more options for treatment,” Todd Cohen,board-certified urologist and vice president of Medical Affairs for Myriad Urology, said in a statement. “NCCN guidelines recommend that men with metastatic castration-resistant prostate cancer undergo genetic testing alongside an assessment of HRR gene mutations in the tumor.”
The collaboration between Myriad and AstraZeneca began in 2007 and has resulted in eight regulatory approvals for BRACAnalysis CDx and myChoice CDx.
