Primary-source record
Decision-gradeFDA approval
Pfizer Talzenna + enzalutamide FDA approved for mAPMN/S HRR-mutated prostate cancer
FDA approved talazoparib (Talzenna) in combination with enzalutamide for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with HRR gene mutations. This is a new indication for the PARP inhibitor in this setting.
Key facts
- Filed
- Oct 27, 2026, 12:36 AM
- Event
- FDA approval
- Direction
- Positive
- Company
PFEPfizer- Asset
- talazoparib
- Source
- FDA announcement
- Confidence
- Sourced
- Calendar
- FDA decision (PDUFA) · Oct 1, 2026 · Approved
- rPFS HR
- 0.48 (95% CI 0.36-0.65)
- anemia grade 3+
- 51%
- 3-year rPFS rate
- 77%
- rPFS risk reduction
- 52%
Source excerpt
FDA approves talazoparib with enzalutamide for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with HRR gene mutations On October 26, 2026, the Food and Drug Administration (FDA) approved talazoparib (Talzenna, Pfizer Inc.) in combination with enzalutamide for the treatment of adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer. Read more.