The FDA has given Pfizer approval for once-daily 0.5 mg Talzenna (talazoparib) with Xtandi (enzalutamide) to treat metastatic prostate cancer.
The combination is indicated for patients with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with homologous recombination repair (HRR) gene mutations. The cancer must be detected by an FDA-authorized test, either FoundationOne CDx or FoundationOne Liquid CDx assays. Patients must also either receive a gonadotropin-releasing hormone (GnRH) analog concurrently or have had a bilateral orchiectomy.
The approval is based on positive results from the TALAPRO-3 trial, where patients received Talzenna-Xtandi or Xtandi with a placebo. Both groups also received androgen deprivation therapy. There was a statistically-significant improvement in progression-free survival of those receiving Talzenna-Xtandi compared to Xtandi with a placebo.
Talzenna capsules were first approved in 2018 for BRCA-mutated, HER2‑negative locally advanced or metastatic breast cancer. In 2023, the Talzenna-Xtandi combo was approved for HRR gene-mutated metastatic castration-resistant prostate cancer.