US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer

CONCLUSION: Despite a statistically significant rPFS improvement in the all-comer cohort, FDA did not consider the magnitude of rPFS clinically meaningful in the context of the broad indication, combination treatment, and safety profile. Approval was therefore limited to patients with HRRm mCRPC, for whom there was a statistically significant and clinically meaningful improvement in rPFS and favorable OS results. This represents the first approval for the first-line treatment of patients with HRRm mCRPC.PMID:38452327 | DOI:10.1200/JCO.23.02182

Source: Clinical Prostate Cancer - March 7, 2024 Category: Cancer & Oncology Authors: Brian L Heiss Elaine Chang Xin Gao Tien Truong Michael H Brave Erik Bloomquist Ankit Shah Salaheldin Hamed Jeffrey Kraft Haw-Jyh Chiu Tiffany K Ricks Amy Tilley William F Pierce Liuya Tang Abdelrahmman Abukhdeir Shyam Kalavar Reena Philip Shenghui Tang Ri Source Type: research