Pfizer announced that the FDA has granted priority review to its application to expand approval for a combination of Talzenna and Xtandi for men with metastatic castration-sensitive prostate cancer whose tumors have HRR gene mutations. Talzenna (a PARP inhibitor) and Xtandi (an androgen-receptor inhibitor) are already approved individually for metastatic prostate cancer that has stopped responding to hormone therapy. The FDA has set a target decision date in the fourth quarter of 2026.
FDA Grants Priority Review to Pfizer’s Talzenna + Xtandi Combo for HRR-Mutant mCSPC; Decision Due Q4 2026
FILE PHOTO: The Pfizer logo is seen in this illustration taken August 3, 2025. REUTERS/Dado Ruvic/Illustration/File Photo
Pfizer said on Wednesday that the U.S. Food and Drug Administration (FDA) has granted priority review to its application seeking expanded approval for a combination therapy of Talzenna and Xtandi in prostate cancer.
The company is asking the FDA to allow the two approved drugs — Talzenna (talazoparib), a PARP inhibitor, and Xtandi (enzalutamide), an androgen-receptor inhibitor — to be used together in men with metastatic castration-sensitive prostate cancer (mCSPC) whose tumors harbor homologous recombination repair (HRR) gene mutations.
Both medicines are already approved in the United States to treat men with metastatic prostate cancer that has progressed after or become resistant to hormone therapy (commonly described as metastatic castration-resistant prostate cancer).
Pfizer said the FDA has set a target action date for the priority review in the last quarter of 2026. Priority review is granted to applications for drugs that could offer significant improvements in the treatment, diagnosis or prevention of serious conditions and typically shortens the review timeline.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shailesh Kuber and Pooja Desai, Reuters)
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