FDA reviews Pfizer's application for Sutent

Pfizer noted that a Type II Variation application for Sutent in the same patient population has been validated for review by the European Medicines Agency.
Pfizer noted that a Type II Variation application for Sutent in the same patient population has been validated for review by the European Medicines Agency. | Contributed image

Pfizer Inc. recently announced that the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for Sutent.

If Pfizer is successful in achieving FDA approval, the accepted use of Sutent will expand to include use as an adjuvant treatment in adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancer-containing kidney). The FDA will make its decision via the Prescription Drug User Fee Act (PDUFA) by Jan. 2018.

“There is currently no approved therapy for patients with kidney cancer post-surgery, and we know that some patients are at risk of their cancer returning,” said Dr. Mace Rothenberg, chief development officer of Oncology for Pfizer Global Product Development, in a statement. “Given our experience with SUTENT in patients with advanced or metastatic kidney cancer, we set out to determine whether SUTENT could reduce the risk of recurrence in high-risk patients.”

In its press release, Pfizer noted that a Type II Variation application for Sutent in the same patient population has been validated for review by the European Medicines Agency (EMA).

According to Pfizer, Sutent is the most commonly used first-line treatment for advanced RCC in the world.

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