According to the company, Gleevec is now the only post-surgery treatment indicated to delay the return of this highly aggressive cancer, filling a major need for gastrointestinal stromal tumors (GIST) patients. The filing received the FDA priority review status in August 2008, with regulatory reviews currently underway in other regions, including the EU and Switzerland.
The approval for this new indication is based on data from a National Cancer Institute-sponsored Phase III study that showed a reduction in the return of GIST after surgery in patients treated for about one year with Gleevec versus placebo. Based on a 14-month median follow up, 91.6% of Gleevec patients remained cancer-free compared with 80.2% of those taking placebo, the company said.
Gleevec is now approved for nine indications, including the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), Kit (CD117)-positive GIST which cannot be surgically removed or have already spread to other parts of the body (metastasized) and five other rare diseases.
David Epstein, president and CEO of Novartis Oncology, said: When Gleevec was first approved for the treatment of inoperable or metastasized Kit-positive GIST six years ago, it revolutionized the treatment of this life-threatening cancer. This latest FDA approval means patients can benefit from Gleevec earlier in the course of their disease.