Pfizer’s TALZENNA Plus XTANDI FDA-Approved for an Earlier Metastatic Prostate Cancer Treatment Setting

TALZENNA plus XTANDI is now approved for HRR gene-mutated metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, offering a potential new standard of care earlier in the course of disease

Approval based on pivotal Phase 3 TALAPRO-3 data, which showed an estimated 52% reduction in the risk of radiographic progression or death

NEW YORK, October 26, 2026--Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has expanded approval of TALZENNA® (talazoparib) in combination with XTANDI® (enzalutamide) to the treatment of men with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (PC) with homologous recombination repair (HRR) gene mutations, including both BRCA and non-BRCA mutations. mAPMN/S is also known as metastatic hormone-sensitive prostate cancer (mHSPC). This approval makes TALZENNA, an oral poly ADP-ribose polymerase (PARP inhibitor), plus XTANDI, an androgen receptor pathway inhibitor (ARPI), available in an earlier line, providing an opportunity to delay disease progression at a critical stage when more patients may experience greater benefit.

"Today's approval of TALZENNA plus XTANDI builds on its established role as a standard-of-care option for men with advanced prostate cancer. Moving this targeted therapy into the androgen pathway modulation-naïve or -sensitive setting further reflects our commitment to men with HRR-mutated metastatic prostate cancer, providing a new option at a stage where it may have a greater impact to delay progression."

- Aamir Malik, Executive Vice President, Chief U.S. Commercial Officer, Pfizer

"This approval represents a critical advancement for patients with newly diagnosed metastatic prostate cancer with HRR gene mutations, who face a more aggressive disease, worse prognosis, and limited treatment options. In the TALAPRO-3 trial, clinical benefits were consistent for patients with BRCA and non-BRCA HRR gene mutations, addressing a long-standing unmet need – and reinforcing the importance of biomarker testing at the time of diagnosis."

- Neeraj Agarwal, M.D., FASCO, Co-director of Prostate Cancer Program at Harvard Cancer Consortium, faculty medical oncologist at Dana-Farber Cancer Institute, and global lead investigator for TALAPRO-3

TALZENNA plus XTANDI 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). The application to expand the indication was reviewed under FDA Priority Review and was supported by results from the Phase 3 TALAPRO-3 study.