FDA approves talazoparib and enzalutamide for metastatic prostate cancer

The FDA has approved the combination of talazoparib (Talzenna) and enzalutamide (Xtandi) for treating patients with metastatic hormone-sensitive prostate cancer (mHSPC) who possess homologous recombination repair (HRR) gene mutations. This approval expands the existing use of the combination, which was previously limited to patients with metastatic castration-resistant prostate cancer (CRPC).

The decision follows results from the phase 3 TALAPRO-3 trial. Data indicated that adding the PARP inhibitor talazoparib to enzalutamide reduced the risk of radiographic progression or death by 52% compared to a placebo plus enzalutamide. The trial included patients with both BRCA and non-BRCA HRR gene alterations, such as BRCA1, BRCA2, ATM, CDK12, and PALB2.

To be eligible for this treatment, patients must have their HRR gene mutations detected by an FDA-authorized test through sequencing tumor tissue or circulating tumor DNA.