FDA Approves Talzenna Plus Xtandi in Hormone-Sensitive Prostate Cancer

The Food and Drug Administration (FDA) on Oct. 26, 2026, approved Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for adults with metastatic androgen pathway modulation-naive or -sensitive prostate cancer with homologous recombination repair (HRR) gene mutations, as detected by an FDA-authorized test.

The approval is based on results from the phase 3 TALAPRO-3 trial, in which Talzenna plus Xtandi was compared with placebo plus Xtandi. Talzenna plus Xtandi was previously approved for some patients with metastatic castration-resistant prostate cancer, which no longer responds to standard hormone therapy.

"Androgen pathway modulation-naive or -sensitive" means the cancer has not yet been treated with drugs that block the androgen (male hormone) pathway, or it is still responding to them. This is often called metastatic hormone-sensitive or castration-sensitive prostate cancer.

The FDA previously approved FoundationOne CDx, which uses a tumor tissue sample, and FoundationOne Liquid CDx, which uses a blood sample, as companion diagnostic tests to find patients with HRR gene alterations who may be eligible for Talzenna plus Xtandi.

How Talzenna Plus Xtandi Affected Prostate Cancer Growth

Median radiographic progression-free survival, the time before scans showed the cancer growing or a patient died, was not reached in the Talzenna plus Xtandi group, meaning more than half of patients had not had their cancer grow at the time of the analysis. Median radiographic progression-free survival was 45.8 months in the placebo plus Xtandi group.

Talzenna plus Xtandi lowered the risk of the cancer growing or death by 52% compared with placebo plus Xtandi.

Who Was Included in the TALAPRO-3 Clinical Trial?

The randomized, double-blind, placebo-controlled trial included 599 patients with HRR gene-mutated metastatic prostate cancer that had not been treated with, or was still responding to, androgen pathway drugs. Patients were randomly assigned to take Xtandi daily with either Talzenna or placebo. All patients also received continuous androgen deprivation therapy, which lowers testosterone.

HRR genes help cells repair damaged DNA. Mutations in the following genes were included: ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2 and RAD51C. Mutation status was determined before enrollment using tumor tissue or blood (circulating tumor DNA) tests.

TALAPRO-3 results were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine, according to Pfizer, which makes Talzenna.

What Is the Recommended Dose of Talzenna?

The recommended dose of Talzenna is 0.5 mg taken by mouth once daily with Xtandi until the cancer grows or side effects become too hard to manage. Patients taking Talzenna and Xtandi should also receive a gonadotropin-releasing hormone (GnRH) analog, a type of hormone therapy, or should have had surgery to remove both testicles (bilateral orchiectomy).

What Are the Side Effects and Risks of Talzenna?

The prescribing information for Talzenna includes warnings for:

• Myelodysplastic syndrome and acute myeloid leukemia, which are blood cancers
• Myelosuppression, or low levels of red blood cells, white blood cells and platelets
• Embryo-fetal toxicity, or harm to an unborn baby

What Patients Should Know About Monitoring During Treatment

Because Talzenna can lower blood cell counts, patients typically need regular blood tests during treatment. Patients should tell their care team about signs such as unusual tiredness, bruising or bleeding, fever or frequent infections. Patients with partners who could become pregnant should ask their care team about using effective birth control during treatment and after their last dose.

References

1. "FDA approves talazoparib with enzalutamide for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with HRR gene mutations." News Release. U.S. Food and Drug Administration. Oct. 26, 2026.
2. "FDA Grants Priority Review for Pfizer's TALZENNA Plus XTANDI for the Treatment of Metastatic Prostate Cancer." Pfizer. July 22, 2026.

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