US FDA approves Pfizer’s Talzenna with Xtandi for prostate cancer

The US Food and Drug Administration (FDA) has granted approval to Pfizer’s Talzenna (talazoparib), along with Xtandi (enzalutamide), for prostate cancer.

The combination therapy is indicated to treat homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) in adult patients.

Talzenna is an oral inhibitor of poly ADP-ribose polymerase (PARP) that plays a role in repairing DNA damage.

It is the first and only PARP inhibitor to receive approval for use along with the current standard of care (Xtandi) for HRR gene-mutated mCRPC.

Pfizer Global Biopharmaceuticals Business president and chief commercial officer Angela Hwang stated: “As a global standard of care, Xtandi has shown efficacy in three types of prostate cancer, and the addition of Talzenna demonstrated significant and clinically meaningful reductions in the risk of progression or death [and also showed prolongation of] progression-free survival in patients with this type of advanced prostate cancer.

“With today’s FDA approval of Talzenna plus Xtandi, we are proud to be able to offer this potentially practice-changing treatment to patients and add to their options in managing this aggressive disease.”

The regulatory approval was based on the findings obtained from the Phase III TALAPRO-2 trial.

The findings showed that mCRPC patients treated with Talzenna and Xtandi had a 55% reduction in the risk of disease progression or death with identified HRR gene mutations, compared to placebo plus Xtandi.

The safety of Talzenna in combination with Xtandi was found to be generally consistent with the known safety profile of each medicine.