Drugs

Amol Akhade on ODAC’s unanimous vote against Talazoparib + Enzalutamide for non-HRRm mCRPC

Amol Akhade/hiranandanihospital.org

May 24, 2025, 19:13

Amol Akhade on ODAC’s unanimous vote against Talazoparib + Enzalutamide for non-HRRm mCRPC

Amol Akhade, Consultant Medical Oncologist at the Suyog Cancer Clinics, shared a post on LinkedIn:

“ODAC Votes 8 – 0 Against Talazoparib + Enzalutamide in non-HRRm mCRPC

In a unanimous 8–0 decision, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted against expanding the label for talazoparib + enzalutamide to include patients with metastatic castration-resistant prostate cancer (mCRPC) who lack HRR mutations.

Key reasons behind the rejection:

– No prespecified statistical analysis for the non-HRRm subgroup
– Immature overall survival (OS) data
– Absence of prospective biomarker stratification
– Lack of supporting data from prior PARP inhibitor trials in non-HRRm patients

Concern that observed benefits may be due to chance.

The committee expressed concern that approving this broad label would set a precedent that rewards inadequate methodology and undermines scientific rigor.

While trends in rPFS were noted (not reached vs. 21.9 months), the absence of rigorous subgroup validation made the case unconvincing.

Takeaway:

The combination remains approved only for HRR-mutated mCRPC Biomarker-driven precision oncology remains the benchmark for regulatory approval Caution urged against exploratory claims without statistical and biological justification

This decision reinforces that regulatory approval must be driven by data, not extrapolation.”

More posts featuring Amol Akhade on OncoDaily.

Amol Akhade cancer Enzalutamide FDA HRR-mutated mCRPC mCRPC metastatic castration-resistant prostate cancer non-HRRm mCRPC ODAC OncoDaily Oncologic Drugs Advisory Committee Oncology Suyog Cancer Clinics Talazoparib

Servier Acquires Precision Therapy for Acute Leukemias from BioNova Pharmaceuticals

Penn Medicine: Cancer Center Near Me

Elevating Childhood Cancer and Catastrophic Diseases in the Global NCD Agenda: Joint Call to Action

Oliver Bogler Announced the Launch of the NanCI AI Webapp for Scientific Literature and Networking

Joe Biden Diagnosed with Aggressive Metastatic Prostate Cancer at Age 82