Pfizer's prostate cancer drug combo gets FDA priority review

Published Jul 23, 09:38 AM UTC

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Pfizer announced on July 23, 2026, that the U.S. Food and Drug Administration (FDA) has granted priority review to its application seeking expanded approval for a combination of two prostate cancer drugs, Talzenna and Xtandi. The expanded approval is sought for men with metastatic castration-sensitive prostate cancer whose tumors have HRR mutations. Both drugs are already approved in the U.S. for men with prostate cancer that has spread and stopped responding to hormone therapy. The FDA has set a target decision date in the last quarter of 2026.

Source report

Pfizer’s Prostate Cancer Drug Combination Receives U.S. FDA Priority Review

Updated: July 23, 2026 02:56 pm IST Source: Reuters

Pfizer announced on Wednesday that the U.S. Food and Drug Administration (FDA) has granted priority review to its application seeking expanded approval for a combination treatment for prostate cancer.

The company is seeking approval to use a combination of two already-approved drugs—branded as Talzenna and Xtandi—for men with metastatic castration-sensitive prostate cancer whose tumors have acquired specific genetic changes known as HRR mutations.

Current Approvals

Talzenna and Xtandi are already approved in the United States for men whose prostate cancer has spread to other parts of the body and has stopped responding to hormone therapy.

Regulatory Timeline

Pfizer stated that the FDA has set a target decision date for the combination drug in the last quarter of 2026.

Image used for representational purposes only. Photo Credit: Getty Images

Published: July 23, 2026 02:55 pm IST

Source

The Hindu: Latest News today from India and the World, Breaking news, Top Headlines and Trending News Videos.Western

Original headline: Pfizer's prostate cancer drug combination gets U.S. FDA priority review

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