Gleevec regulatory update

The U.K.'s NICE issued guidance recommending against the use of Glivec imatinib from Novartis for adjuvant treatment of gastrointestinal stromal tumors (GIST) after surgery. The guidance is in line with a June final appraisal determination (FAD) (see BioCentury, June 28). The committee, however, recommended that an early review date be set in June 2011 to reconsider its guidance once data are available from the company's ongoing Phase III EORTC 62024 and SSG XVIII trials evaluating adjuvant Glivec in the indication. ...