Launch Catch-Up — Regulatory Decision Announced October 26, 2026
The Food and Drug Administration approved talazoparib, sold as Talzenna, with enzalutamide for certain adults with metastatic prostate cancer on October 26.
The approval applies to cancers with homologous recombination repair gene mutations detected by an FDA-authorized test and described as androgen pathway modulation-naïve or -sensitive.
FDA evaluated TALAPRO-3, a randomized trial involving 599 patients. Participants received enzalutamide with either talazoparib or placebo, alongside continuous androgen deprivation therapy.
The combination improved the study's imaging-based measure of progression-free survival. Median progression-free survival had not yet been reached in the talazoparib group, compared with 45.8 months in the comparison group. Overall-survival data were immature when that analysis was conducted, so these findings do not establish a mature survival result.
The prescribing information warns about myelodysplastic syndrome or acute myeloid leukemia, suppression of blood-cell production and embryo-fetal toxicity.
FDA said Australian and Canadian regulators participated through Project Orbis, but their application reviews remained ongoing. U.S. approval therefore does not establish approval in those countries.
Sources: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-talazoparib-enzalutamide-metastatic-androgen-pathway-modulation-naive-or-sensitive