Pfizer Secures FDA Approval for Talazoparib Combination for mAPMN/S Prostate Cancer with HRR Gene Mutations

01:21 PM EDT, 10/26/2026 (MT Newswires) -- Pfizer's (PFE) talazoparib, or Talzenna, was approved by the US Food and Drug Administration in combination with enzalutamide to treat adults with metastatic androgen pathway modulation-naive or -sensitive prostate cancer with homologous recombination repair gene mutations, as detected by an authorized test, the agency said Monday. The approval was based on the results of Pfizer's phase 3 study demonstrating a statistically significant improvement in radiographic progression-free survival, the agency said. The recommended talazoparib dose is 0.5 mg orally per day with enzalutamide until disease progression or unacceptable toxicity., the FDA said. Price: 29.80, Change: -0.23, Percent Change: -0.78