Gastrointestinal stromal TUMORS (GIST): FDA approves Gleevec ® over 3 years

News published there is 5h08mn

Food and Drug Administration

The Food and Drug Administration (FDA) has approved Gleevec ® (imatinib) Novartis in treatment of 3 years, after surgery for patients with gastrointestinal stromal tumors (IMTS). Glivec has just demonstrated in a trial of phase III efficacy to reduce 54% risk of recurrence and death in these patients, treatment of 3 years vs 1 year.

This approval based on history over 10 years of use of Gleevec for treatment of the IMTS was the subject of a priority assessment procedure FDA. An update of the record for Glivec ® (imatinib) will therefore be carried out with the recommendation for treatment of 36 months after surgery, for adult patients with gastrointestinal stromal tumors (GIST) KIT (CD117) positive.

These 36 months of Glivec treatment resulted in a reduction of 54% of the risk of recidivism and 55% of the risk of death from a year of treatment, according to the results…

Read the whole article