Pfizer's TALZENNA in Combination with XTANDI Approved by U.S. FDA

Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved TALZENNA (talazoparib) in combination with XTANDI (enzalutamide). The drug combination is indicated for adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed despite prior treatment.

The FDA approval was based on results from the Phase 3 TALAPRO-2 clinical trial. The study demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS). Patients treated with TALZENNA plus XTANDI experienced a 55% reduction in the risk of disease progression or death compared to those who received placebo plus XTANDI.

Metastatic castration-resistant prostate cancer (mCRPC) is an advanced form of prostate cancer that has spread and progressed despite medical or surgical treatment to lower testosterone levels. HRR gene mutations are found in approximately 25% of mCRPC tumors and are associated with more aggressive disease and poorer prognosis.

"The FDA's approval of the talazoparib and enzalutamide combination, based on the TALAPRO-2 study, represents a significant advancement for patients with HRR gene-mutated mCRPC," said Dr. Neeraj Agarwal, global lead investigator for TALAPRO-2. "This combination offers a new treatment option that can meaningfully delay disease progression or death."

Pfizer stated that this approval provides a potentially practice-changing treatment option for patients managing this aggressive disease. The company has also submitted applications to other regulatory agencies, including a marketing authorization application to the European Medicines Agency.