Pfizer's Talzenna (talazoparib) in combination with Xtandi (enzalutamide) demonstrated a statistically significant overall survival benefit in patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC) in the Phase 3 TALAPRO-2 trial2
The combination achieved a 38% reduction in the risk of death, with a 14-month gain in median overall survival (45.1 months vs. 31.1 months) compared to standard care in HRR-mutated mCRPC patients2
The FDA approved Talzenna with enzalutamide for HRR gene-mutated mCRPC on June 20, 2023456
The UK's NICE recommended Talzenna-Xtandi for NHS use in metastatic prostate cancer on January 23, 2025, reversing a previous negative stance after public consultation13
NICE approved the combination for patients with metastatic prostate cancer who are ineligible for standard hormonal therapy plus corticosteroid combinations such as abiraterone-prednisolone1
Pfizer is pursuing first-line use of Talzenna-Xtandi in HRR-mutated metastatic castration-sensitive prostate cancer through the Phase 3 TALAPRO-3 trial7
Talzenna is a PARP inhibitor that blocks the repair of single-strand DNA breaks in cancer cells, causing genomic instability and cancer cell death1
Sources:
1. https://www.pharmaceutical-technology.com/news/uk-nice-recommends-pfizer-talzenna-metastatic-prostate-cancer/
2. https://www.pfizer.com/news/announcements/pfizer-provides-update-us-regulatory-review-talzenna-combination-xtandi-broader
3. https://pharmaphorum.com/news/change-heart-nice-backs-prostate-cancer-drug-talzenna
4. https://www.jhoponline.com/issue-archive/2023-issues/august-2023-vol-13-no-4/talzenna-received-a-new-indication-with-enzalutamide-for-metastatic-castration-resistant-prostate-cancer-with-hrr-gene-mutation
5. https://www.valuebasedcancer.com/issues/2023/august-2023-vol-14-no-4/talzenna-receives-new-indication-with-enzalutamide-for-metastatic-castration-resistant-prostate-cancer-with-hrr-gene-mutation
6. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-talazoparib-enzalutamide-hrr-gene-mutated-metastatic-castration-resistant-prostate
7. https://www.pfizer.com/pfizer-pipeline-key-anticipated-2026-catalysts