July 22 (Reuters) – Pfizer said on Wednesday the U.S. Food and Drug Administration has granted priority review to its application seeking expanded approval for its prostate cancer treatment combination.
The company sought expanded approval to use a combination of two approved drugs branded as Talzenna and Xtandi in men with metastatic castration-sensitive prostate cancer, whose tumors have acquired gene changes known as HRR mutations.
Talzenna and Xtandi are already approved in the United States for men whose prostate cancer has spread to other parts of the body and stopped responding to hormone therapy.
For the combination drug, Pfizer said the FDA had set a target decision date in the last quarter of 2026.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shailesh Kuber and Pooja Desai)
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