ARTICLE | Clinical News

Glivec imatinib regulatory update

October 20, 2014 7:00 AM UTC

The U.K.'s NICE issued a final appraisal determination (FAD) recommending 400 mg daily Glivec imatinib from Novartis for adjuvant treatment for up to 3 years in adults who are at high risk of relapse for stem cell factor ( SCF) receptor tyrosine kinase (c-Kit; KIT; CD117)-positive gastrointestinal stromal tumors (GIST). The FAD reverses guidance NICE issued in 2010 recommending against Glivec for the indication because clinical evidence was "too immature" to draw conclusions about clinical effectiveness (see BioCentury, June 28, 2010).

Novartis submitted additional data, including data from a Phase III trial showing that adjuvant treatment with Glivec increased the 1-year recurrence-free survival rate to 98% vs. 83% for placebo (p<0.0001). Another Phase III trial showed that adjuvant treatment with Glivec for 3 years significantly improved recurrence-free survival and OS vs. adjuvant treatment with Glivec for 1 year. The committee concluded that the incremental cost-effective ratio (ICER) per quality-adjusted life-year (QALY) was L3,610-L12,100 ($5,806-$19,462) for 1-year adjuvant Glivec compared with no adjuvant treatment and L16,700-L30,000 ($26,860-$48,252) for 3-year adjuvant Glivec compared to 1-year adjuvant Glivec. ...