Recent Updates
Recently added Catalysts
PFE Positive Sentiment Score: 80/100

FDA Grants Priority Review for Pfizer’s TALZENNA Plus XTANDI for the Treatment of Metastatic Prostate Cancer

Key Takeaway: Pfizer announced that the FDA has accepted for Priority Review a supplemental New Drug Application for TALZENNA in combination with XTANDI. This treatment is aimed at men with homologous recombination repair gene-altered metastatic castration-sensitive prostate cancer. The Priority Review designation may accelerate the approval timeline for this therapy.

Market Sentiment Analysis

POSITIVE FACTORS

  • FDA accepted the sNDA for TALZENNA and XTANDI.
  • Priority Review status expedites the approval process.
  • Combination therapy targets a specific patient population.

Full Press Release Details

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC), also known as meta

Frequently Asked Questions

What is TALZENNA used for?

TALZENNA is a PARP inhibitor used for treating metastatic prostate cancer.

What does Priority Review mean?

Priority Review expedites the FDA's review process for new therapies.

Who is the target patient group for this therapy?

The therapy targets men with HRR gene-altered metastatic castration-sensitive prostate cancer.

What is the role of XTANDI in this treatment?

XTANDI is an androgen receptor pathway inhibitor used in combination with TALZENNA.

Last updated: Jul 22, 2026