Posted by Michael Wonder on 03 Jun 2017
Pfizer announces acceptance of regulatory submissions by U.S. FDA and EMA for Sutent (sunitinib) for adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma after surgery
31 May 2017 - Applications seek to expand approved use of Sutent based on data from the Phase 3 S-TRAC trial.
Pfizer today announced that a supplemental new drug application for Sutent (sunitinib) has been accepted for filing by the U.S. FDA. If approved, the application would expand the approved use of Sutent to include use as an adjuvant treatment in adult patients at high risk of recurrent renal cell carcinoma following nephrectomy (surgical removal of the cancer-containing kidney).
In addition, the EMA has validated for review a Type II Variation application for Sutent in the same patient population. Sutent is the most widely prescribed first-line treatment for advanced renal cell carcinoma worldwide.
The Prescription Drug User Fee Act goal date for a decision by the FDA is in January 2018.
