On October 26, 2026, local time, Pfizer Inc. announced that the U.S. Food and
Drug Administration (FDA) has expanded the approval of talazoparib (Talzenna) in
combination with enzalutamide (Xtandi) for the treatment of men with metastatic
androgen pathway modulation-naive or sensitive (mAPMN/S) prostate cancer (PC)
harboring homologous recombination repair (HRR) gene mutations, including BRCA
and non-BRCA mutations.
mAPMN/S is also known as metastatic hormone-sensitive prostate cancer (mHSPC).
This approval moves the oral PARP inhibitor Talzenna combined with the androgen receptor pathway inhibitor (ARPI) Xtandi into an earlier treatment line, providing an opportunity to delay disease progression at a more critical stage and potentially allowing more patients to benefit.
Approval Highlights
Talzenna combined with Xtandi is now approved for mAPMN/S prostate cancer harboring HRR gene mutations and is expected to become a potential new standard of care earlier in the disease course.
This approval is based on data from the pivotal Phase 3 TALAPRO-3 study: the combination reduced the estimated risk of radiographic progression or death by 52%.
Talzenna combined with Xtandi was first approved in the United States in 2023 for metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer harboring HRR gene mutations, i.e., HRRm metastatic castration-resistant prostate cancer (mCRPC).
This indication expansion application was completed under FDA priority review and was supported by the results of the Phase 3 TALAPRO-3 study.
About mAPMN/S Prostate Cancer
mAPMN/S prostate cancer is an advanced prostate cancer that has spread beyond the prostate but remains sensitive to androgen deprivation therapy. About 25% of patients with mAPMN/S prostate cancer (mHSPC) carry HRR gene mutations.
FDA Indications for Talazoparib
Talazoparib is a PARP inhibitor. Its U.S. FDA indications include:
Breast cancer
As monotherapy for adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer. Patients should be selected based on an FDA-authorized companion diagnostic.
Prostate cancer
In combination with enzalutamide for the treatment of adult patients with:
mAPMR prostate cancer harboring HRR gene mutations confirmed by an FDA-authorized test;
mAPMN/S prostate cancer harboring HRR gene mutations confirmed by an FDA-authorized test.
FDA Indications for Enzalutamide
Enzalutamide’s U.S. FDA indications are for the treatment of patients with:
Castration-resistant prostate cancer (CRPC);
Metastatic castration-sensitive prostate cancer (mCSPC);
Non-metastatic castration-sensitive prostate cancer (nmCSPC) with high-risk biochemical recurrence (high-risk BCR).
