FDA Advisory Committee Unanimously Votes Against Expanding Pfizer’s Prostate Cancer Drug Combo

On May 21, 2025, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted unanimously against the use of Pfizer's Talzenna (talazoparib) in combination with enzalutamide for metastatic castration-resistant prostate cancer (mCRPC) in patients not selected for homologous recombination repair (HRR) gene mutations34.

The proposed expansion would have made Talzenna the first PARP inhibitor approved for mCRPC regardless of HRR mutation status13.

Panelists raised concerns about the efficacy and benefit-risk profile of the drug combo in patients without HRR mutations, emphasizing the importance of biomarker-driven treatment selection3.

The vote followed results from the TALAPRO-2 trial, which evaluated the combination in a broader, biomarker-unselected mCRPC population3.

The committee's decision is a significant setback for Pfizer's efforts to broaden the label for Talzenna in prostate cancer treatment4.

Sources:

1. https://www.targetedonc.com/view/odac-rejects-label-expansion-for-talazoparib-in-non-hrrm-mcrpc

3. https://www.urologytimes.com/view/live-updates-fda-advisory-committee-on-talazoparib-plus-enzalutamide-for-mcrpc

4. https://www.biopharmadive.com/news/pfizer-talzenna-prostate-sarepta-envision-altos-dorian/748686/