FDA Approves Talazoparib + Xtandi for HRR-mutated mCRPC

Published

July 26, 2025

Author

Lansbury Sinclair

Lansbury is an intelligence analyst focused on immunology. She tracks clinical and market developments across psoriasis, psoriatic arthritis, and lupus.

In June 2025, Pfizer’s Talazoparib + Xtandi combo received FDA approval for treatment of HRR-mutated metastatic castration-resistant prostate cancer(mCRPC). The approval was based on the TALAPRO-2 trial, which demonstrated a37% rPFS improvement overall and 55% in HRR-positive subgroups. This combo joins Lynparza and Akeega in an increasingly competitive HRR-targeted mCRPC space.

Citation: https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-talazoparib-plus-xtandi-combination-hrr

‍Implication: Talazoparib + Xtandi’s entrance underscores urgency in reinforcing Akeega’s messaging around dual-target inhibition, patient convenience, and BRCA specificity.