Pfizer Receives the US FDA’s Approval of Talzenna (talazoparib) + Xtandi (enzalutamide) for the Treatment of Prostate Cancer
Shots:
- The US FDA has approved Talzenna + Xtandi for adult patients with HRR gene-mutated mCRPC. The approval was based on the P-III trial (TALAPRO-2) incl. 2 patient cohorts i.e., cohort 1 (all-comers; n=805) & cohort 2 (those with HRR (mutations; n=399) evaluating Talzenna + Xtandi vs PBO + Xtandi in 1125 patients
- The results showed a 55% reduction in risk of disease progression or death with prospectively identified HRR gene mutations (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C). The safety was consistent with the known safety profile of each therapy
- Serious ARs (30%) & discontinuation of Talzenna (10%). The results from the (TALAPRO-2) cohort 1 were published in The Lancet while the final OS data is expected in 2024
Ref: Pfizer | Image: Pfizer
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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.
