Visit the ACCC COVID-19 Resource Center & Discussion Group for Insights on Providing Optimal Patient Care During the Pandemic.

Industry News Archive

FDA Approves Olaparib for HRR Gene-Mutated mCRPC

On May 19, 2020, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone.

On the same day, the FDA also approved FoundationOne CDx (Foundation Medicine, Inc.) for selection of patients with mCRPC carrying HRR gene alterations and BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) for selection of patients with mCRPC carrying germline BRCA1/2 alterations as companion diagnostic devices for treatment with olaparib.  

Read full FDA announcement.

Posted 5/20/2020


1801 Research Boulevard Suite 400
Rockville, MD 20850
Tel: 301.984.9496 | Fax: 301.770.1949
ios-indiana.com
Email Us