NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) on Monday announced that the U.S. FDA expanded approval of Talzenna plus Xtandi in the treatment of men with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (PC), also known as metastatic hormone-sensitive prostate cancer.
The indication includes both BRCA and non-BRCA mutations and covers disease that has spread beyond the prostate but remains sensitive to androgen deprivation therapy. The approval followed Priority Review and was supported by the Phase 3 TALAPRO-3 trial, which enrolled 599 patients.
The results demonstrated that the combination reduced the risk of radiographic progression or death by 52% compared with placebo plus xtandi, thereby meeting the primary endpoint. Meanwhile, an estimated 77% of combination-treated patients remained progression-free at three years.
The company said no new safety signals emerged during the study.
Talzenna, or talazoparib, inhibits PARP, a protein involved in DNA repair. Xtandi, or enzalutamide, blocks androgen receptor signaling.
The combination was first approved in the U.S. in 2023 for men with metastatic androgen pathway modulation resistant (mAPMR) PC with HRR gene mutations, also known as HRRm metastatic castration-resistant prostate cancer (mCRPC).
PFE closed at $29.79, down 0.80%.
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