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Pfizer’s prostate cancer drug combination gets U.S. FDA priority review

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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.

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