Pfizer's prostate cancer drug combination gets U.S. FDA priority review
The U.S. FDA has granted priority review to Pfizer's application for a combination prostate cancer treatment using Talzenna and Xtandi. The treatment targets patients with metastatic castration-sensitive prostate cancer who have specific HRR gene mutations.
Why it matters
Priority review status accelerates the availability of potentially life-saving cancer therapies, impacting both patient outcomes and pharmaceutical market dynamics.
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.
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