PDUFAApproval decision

Talzenna/Talazoparib + Xtandi/Enzalutamide (BMN 673 + MDV3100) (PARP Inhibitor)

HRR Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer

PFEPfizer

Expected catalystDecember 31, 2026Company guidance: Dec 31, 2026

Catalyst overview

Event details

Drug or asset: Talzenna/Talazoparib + Xtandi/Enzalutamide (BMN 673 + MDV3100) (PARP Inhibitor)
Development stage: PDUFA
Event type: Approval decision
Indication: HRR Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for Talzenna/Talazoparib + Xtandi/Enzalutamide (BMN 673 + MDV3100) (PARP Inhibitor) in HRR Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer. The expected timing is based on the latest available company guidance and may change.

Development notes

03/19/26:- TALAPRO-3 Ph3 topline positive in HRR-mutated mCSPC; submission to congress and regulator discussions planned. 04/21/26:- TALAPRO-3 subgroup rPFS and OS-trend data at ASCO 2026 on May 30, 2026. 07/22/26:- FDA accepted sNDA; PDUFA action date set for Q4 2026.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source