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Pfizer's Prostate Cancer Drug Gets FDA Priority Review
23 Jul
Summary
- FDA grants priority review for Pfizer's prostate cancer drug combo.
- Expanded approval sought for Talzenna and Xtandi combination therapy.
- Decision on the drug combo expected in the last quarter of 2026.
The U.S. Food and Drug Administration (FDA) has granted priority review for Pfizer's application to expand the approval of its prostate cancer treatment. This expedited review is for a combination therapy using Pfizer's drugs Talzenna and Xtandi.
The expanded approval is sought for treating men with metastatic castration-sensitive prostate cancer who have specific gene mutations, known as HRR mutations. This combination is already approved in the U.S. for a more advanced form of the disease.
Data from a 599-patient trial demonstrated that the Talzenna and Xtandi combination reduced the risk of disease progression or death by 52% compared to Xtandi with a placebo. The European Medicines Agency is also reviewing the combination for the same indication.
Pfizer anticipates a target decision date from the FDA in the last quarter of 2026. This potential expanded approval is part of Pfizer's strategy to drive growth through its oncology and weight-loss drug portfolios amid declining COVID-19 product sales.
