Lisa Jones, United States says,
Michael Gleason, United States says,
Donald Albright, United States says,
Fredrick Hyatt, United States says,
Kimberly Arnoldt, United States says,
Louis Tammaro, United States says,
US FDA Approves Novartis' Gleevec Drug Label Change
Novartis announces the US Food and Drug Administration (FDA) approval of the label change for its anti-cancer drug Gleevec (imatinib mesylate) to treat CD117-positive gastrointestinal stromal tumor (GIST) patients after surgery. A recent clinical study showed better results such as 54% recurrence-free survival and 55% reduced death risk in gastrointestinal cancer patients with 36 months of Gleevec treatment compared to 12 months of Gleevec treatment.
With nearly 6000 new cases of GIST reported annually (according to Novartis), FDA’s approval of expanded use of Gleevec drug will help GIST patients to effectively manage the disease.