Novartis To Submit Gleevec sNDA In September For GI Stromal Tumors
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Novartis expects to submit a Gleevec sNDA for treatment of gastrointestinal stromal tumors (GIST) in September, Novartis President Daniel Vasella, MD, told analysts June 5. The sNDA will be based on results from a single Phase II study.