Pfizer declares update on EMAP for SUTENT in RCC patients

Pfizer asserted that the Committee for Medicinal Products for human use of the European Medicines Agency has disapproved of expanding use of SUTENT to encompass the adjuvant treatment of adult patients who are at high risk of recurrent renal cell carcinoma.

The CHMP’s recommendation is not binding but will now be taken into consideration by the European Commission (EC). There is currently no approved adjuvant treatment option available for patients with non-metastatic RCC at high risk for recurrence in the European Union (EU).

Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development said “We remain confident in the potential of SUTENT for RCC patients at high risk of their cancer returning after surgery who today are restricted to a wait and see, or more accurately, a wait and worry approach.”

The U.S. Food and Drug Administration approved an expanded indication for SUTENT on November 16, 2017  as the first treatment for adult patients at high risk of recurrence following nephrectomy. The FDA expanded indication was based on results from the S-TRAC trial, a multicenter, international, randomized, double-blind, placebo-controlled Phase 3 trial of SUTENT versus placebo in 615 patients with clear cell histology and high risk of recurrence following nephrectomy. The results were published by The New England Journal of Medicine in October 2016.