AstraZeneca and MSD’s Lynparza (olaparib) Receive the US FDA’s Approval for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
Shots:
- The US FDA has approved Lynparza + abiraterone & prednisone or prednisolone for deleterious or suspected deleterious BRCA-mutated mCRPC
- The approval was based on the subgroup analysis of the P-III trial (PROpel) evaluating Lynparza vs PBO in combination with abiraterone, prednisone, or prednisolone in 796 patients, showed an improvement in rPFS & OS over abiraterone alone, m-rPFS (not reached vs 8mos.) & m-OS (not reached vs 23mos.), 76% reduction in risk of disease progression or death, safety & tolerability profile was consistent with prior trials & known profiles of the individual therapies
- The combination therapy was approved in the EU & multiple other countries for mCRPC, Lynparza was approved in the US as monotx. for HRR gene-mutated mCRPC; and in the EU, Japan & China for BRCAm mCRPC
Ref: Astrazeneca | Image: Astrazeneca
Related News:- Merck and AstraZeneca's Lynparza (Olaparib) Receive NICE Recommendation for Maintenance Treatment of BRCA-Mutated Cancers
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
