talazoparib (Talzenna): FDA status

Not approved (CRL) Not approved (CRL) Jun 17, 2025. Indication: non HRR mutated metastatic castration resistant prostate cancer.

Regulatory history

• Jun 17, 2025: Complete response letter. FDA declined to expand label for talazoparib plus enzalutamide to mCRPC patients without HRR mutations. OncLive
• May 21, 2025: Advisory committee. FDA ODAC voted against expanding Talazoparib label to non HRRm mCRPC patients. Targeted Oncology

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