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Pfizer says CHMP recommends against expanding use of SUTENT.

Pfizer announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended against expanding use of SUTENT to include the adjuvant treatment of adult patients at a high risk of recurrent renal cell carcinoma following nephrectomy. The CHMP's recommendation is not binding but will now be taken into consideration by the European Commission. There is currently no approved adjuvant treatment option available for patients with non-metastatic RCC at high risk for recurrence in the European Union. In the U.S., SUTENT is approved for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. On November 16, 2017, the U.S. Food and Drug Administration approved an expanded indication for SUTENT 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.

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Publication:The Fly
Date:Feb 23, 2018
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