FDA Updates Label for Pfizer's TALZENNA/XTANDI Prostate Cancer Treatment

Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has concluded its review of the supplemental New Drug Application (sNDA) for TALZENNA® (talazoparib) in combination with XTANDI® (enzalutamide) for men with metastatic castration-resistant prostate cancer (mCRPC). The FDA has approved updated labeling that includes final overall survival (OS) data for the combination's existing indication in adults with homologous recombination repair (HRR) gene-mutated mCRPC. However, the agency did not expand the indication to include patients with non-HRR gene mutated mCRPC.

The decision, based on data from the Phase 3 TALAPRO-2 trial, means the combination will continue to be indicated for HRR-mutated mCRPC but will not be approved for patients with non-HRR mutations in the United States. The FDA determined that the trial data were not sufficient to establish a favorable benefit-risk profile for the broader patient group with non-HRR gene mutations. Consequently, Pfizer will not proceed with seeking an expanded indication for this combination in the U.S.

Johanna Bendell, M.D., Oncology Chief Development Officer at Pfizer, stated that TALZENNA in combination with XTANDI has redefined the standard of care for patients with HRR gene-mutated mCRPC. She expressed satisfaction that the statistically significant final overall survival data reaffirming the current indication have been added to the label.

Results from the TALAPRO-2 trial showed that the combination of TALZENNA and XTANDI resulted in a median overall survival of 45.1 months for patients with HRR-mutated mCRPC, compared to 31.1 months for patients treated with XTANDI and placebo. This represents a 38% reduction in the risk of death and a 14-month increase in median overall survival.