Supplemental NDA Submitted for Gleevec

EAST HANOVER, NJ—Novartis has submitted a supplemental new drug application (sNDA) to the FDA seeking approval for Gleevec (imatinib mesylate) for the treatment of patients with unresectable and/or metastatic malignant gastrointestinal stromal tumors (GISTs). Last May, Gleevec received FDA approval for the treatment of patients with chronic myeloid leukemia in the blast crisis, accelerated phase, or in chronic phase after failure of interferon-alfa.

The submission is supported by data from a phase II, open-label study of 147 patients with unresectable or metastatic malignant GIST randomized to receive 400 mg or 600 mg of Gleevec daily for up to 24 months. The overall response rate is 40%, the company said, based on confirmed partial responses at the time of the data cut-off for the submission. An additional 32% of patients achieved a clinically significant reduction in tumor size. Only 12% progressed.