FDA approves talazoparib combination for specified metastatic prostate cancers
The October 26 approval covers talazoparib with enzalutamide for adults with specified HRR gene-mutated metastatic prostate cancer, as detected by an FDA-authorized test.
What the record says
The FDA announced on October 26 that it approved talazoparib, marketed as Talzenna, in combination with enzalutamide for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with homologous recombination repair gene mutations detected by an FDA-authorized test. The agency says the approval was supported by TALAPRO-3, a randomized trial involving 599 patients. FDA reported an improvement in radiographic progression-free survival; overall survival data were immature at the time of that analysis. The prescribing information includes warnings for myelodysplastic syndrome or acute myeloid leukemia, myelosuppression and embryo-fetal toxicity.
Source details and supporting locations.
Practical next step
Patients and clinicians can consult the FDA announcement and current prescribing information when discussing eligibility and treatment.
Limits and what is not established
This is an attributed regulatory approval report, not individualized treatment advice or a claim of demonstrated overall survival benefit. Eligibility depends on the specified disease setting and gene testing.
Sources checked October 27, 2026. Later notices may change instructions or arrangements.
Original sources
U.S. Food and Drug Administration: original information