July 22 (Reuters) – Pfizer said on Wednesday the U.S. Food and Drug Administration had granted priority review to its application seeking expanded approval for its prostate cancer treatment combination.
The company had 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 gene changes, known as HRR mutations.
The combination has already been approved in the United States to treat men with gene-mutated metastatic castration-resistant prostate cancer, an advanced form of the disease.
Priority review shortens the FDA’s review period to six months from the standard 10 months, and is granted to applications for drugs that could significantly improve the treatment, diagnosis or prevention of serious conditions.
Pfizer is counting on its portfolio of oncology and weight-loss drugs as well as recently acquired assets to drive growth, as the New York-based drugmaker seeks to cushion the impact from waning COVID-19 product sales.
Pfizer’s application is backed by data from a late-stage trial involving 599 patients, which showed that the combination of Talzenna and Xtandi reduced the risk of disease progression seen on imaging scans or death by 52% compared with Xtandi and a placebo.
The combination is also under review by the European Medicines Agency for the same prostate cancer use, Pfizer said.
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, Pooja Desai and Diti Pujara)
