Prostate Cancer Treatments in the FDA Pipeline: What Could Come Next

Prostate cancer had a strong summer at the FDA, with two approvals in June and July that moved targeted and radioligand therapy earlier in the disease. So what's next? One combination is under active FDA review with a decision expected before the end of the year, and several phase 3 trials are due to read out in the months ahead. Here is where things stand as of early September.

Talzenna Plus Xtandi for HRR-Mutated Castration-Sensitive Prostate Cancer

Decision expected: Fourth quarter of 2026

Talzenna (talazoparib), a PARP inhibitor, is already approved with Xtandi (enzalutamide) for metastatic castration-resistant prostate cancer with mutations in homologous recombination repair (HRR) genes such as BRCA1 and BRCA2. The new application, granted priority review in July, would move the combination earlier, to metastatic castration-sensitive disease, the point at which hormone therapy still works.

The filing is based on the phase 3 TALAPRO-3 trial of 599 men with HRR-mutated metastatic castration-sensitive prostate cancer. Adding Talzenna to Xtandi reduced the risk of the cancer progressing on imaging or death by 52% compared with Xtandi alone. At three years, 77% of men on the combination were free of radiographic progression versus 56% on Xtandi alone. The benefit held across BRCA and non-BRCA mutations, and overall survival data, while not yet mature, trend in the combination's favor. Read more.

Side effects to know: The most common were decreased hemoglobin (79%), decreased neutrophils (60%), fatigue (49%) and low platelets (45%). Myelodysplastic syndrome or acute myeloid leukemia occurred in 0.4% of patients.

What it means: Roughly a quarter of men with metastatic prostate cancer carry an HRR mutation, and this would be the first PARP inhibitor combination approved for them before the cancer becomes resistant to hormone therapy. "Current treatment approaches leave many patients with HRR gene-mutated metastatic castration-sensitive prostate cancer vulnerable to early disease progression," said Dr. Neeraj Agarwal, the trial's lead investigator. Genetic testing at diagnosis will matter more than ever if this is approved.

Late-Stage Trials That Could Produce the Next Filings

Mevrometostat (Pfizer). An EZH2 inhibitor designed to resensitize prostate cancer to hormone therapy, mevrometostat is being tested with Xtandi in two phase 3 trials, MEVPRO-1 in previously treated metastatic castration-resistant disease and MEVPRO-2 in earlier-line disease. Pfizer expects MEVPRO-1 to read out in the second half of 2026, making it the most likely candidate for a new prostate cancer filing by early 2027.

Opevesostat (Merck). A first-in-class CYP11A1 inhibitor that shuts down androgen production at its source, opevesostat is in two phase 3 trials, OMAHA-003 and OMAHA-004, for metastatic castration-resistant prostate cancer after hormone therapy and chemotherapy. Results are pending.

TLX591 (Telix). This PSMA-targeted radioligand uses an antibody rather than the small molecule in Pluvicto. Part 1 of the phase 3 ProstACT Global trial met its safety objectives, and the FDA has cleared the trial to advance to Part 2 in the U.S.

Earlier in the Pipeline

Three experimental therapies have received fast track designation, which speeds review but does not guarantee approval. HLD-0915, an oral drug that links the androgen receptor to a protein cancer cells need to survive, is in a phase 1/2 trial for metastatic castration-resistant disease. 67Cu-SAR-bisPSMA, a copper-based radioligand, is in early trials for the same population. And Enolen, an implant that releases Xtandi directly into the prostate for two years or more, is in a phase 1 trial for low- to intermediate-risk localized disease, a setting where drug treatment has rarely been an option.

What the FDA Already Approved in 2026

For readers catching up, the FDA approved Truqap (capivasertib) with Zytiga (abiraterone) and prednisone on June 12 for PTEN-deficient metastatic hormone-sensitive prostate cancer, the first targeted therapy for that group, and Pluvicto with hormone therapy on July 31 for PSMA-positive metastatic hormone-sensitive disease, moving radioligand therapy into the first line. Together with Talzenna plus Xtandi, the pattern is clear: the FDA is steadily pushing prostate cancer's most powerful therapies earlier in the disease, and biomarker testing for PTEN, HRR and PSMA is becoming essential to knowing which one applies to you.

If you have metastatic prostate cancer and have not had genetic and PSMA testing, ask your care team, and ask whether a clinical trial of one of these pipeline drugs is enrolling near you.

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References

1. Pfizer. FDA grants priority review for Pfizer's Talzenna plus Xtandi for the treatment of metastatic prostate cancer. July 22, 2026. https://www.pfizer.com/news/press-release/press-release-detail/fda-grants-priority-review-pfizers-talzenna-plus-xtandi
2. Pfizer. Phase 3 TALAPRO-3 trial meets primary endpoint (via Urology Times). March 19, 2026. https://www.urologytimes.com/view/phase-3-talapro-3-trial-meets-primary-end-point-in-hrr-mutated-mcspc
3. BioSpace. ASCO: Pfizer scores in lung, colorectal and prostate cancer but key readouts still to come. https://www.biospace.com/drug-development/asco-pfizer-scores-in-lung-colorectal-and-prostate-cancer-but-key-readouts-still-to-come
4. Telix Pharmaceuticals. 2026 half-year results. Aug. 20, 2026. https://www.biospace.com/press-releases/telix-2026-half-year-results-strong-commercial-execution-and-momentum-in-late-stage-pipeline
5. Urology Times. FDA grants fast track designation to Enolen for localized prostate cancer. Jan. 8, 2026. https://www.urologytimes.com/view/fda-grants-fast-track-designation-to-enolen-for-localized-prostate-cancer
6. OncLive. FDA approves capivasertib plus abiraterone and prednisone for PTEN-deficient mHSPC. June 12, 2026. https://www.onclive.com/view/fda-approves-capivasertib-plus-abiraterone-and-prednisone-for-pten-deficient-mhspc