Novartis receives additional EU approvals for Glivec

Glivec is used in the treatment of a rapidly progressive leukemia and hard-to-treat solid cancer tumors. Both are rare and potentially life-threatening diseases with few, if any, approved treatments that have resulted in poor long-term outcomes. Glivec in combination with standard chemotherapy has shown to restore normal blood count in 96% of patients with Ph+ acute lymphoblastic leukemia.

Glivec was initially approval for treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia which is a rapidly progressive blood cancer characterized by the presence of the Philadelphia chromosome.

Glivec was also approved for treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) who are not eligible for surgery. DFSP begins as a hard lump found in the skin of the chest, abdomen or leg, and progresses to invade nearby tissues.

“Understanding the targets against which Glivec works has led to the unique opportunity to treat two rare diseases that have Glivec-sensitive pathways,” said David Epstein, President of Novartis Oncology. “These two new indications underscore how cancers and diseases of different origin and location share common molecular characteristics that can often respond to the same targeted treatment.”

Submissions in the EU for three other rare diseases remain under review by the Committee for Medicinal Products for Human Use (CHMP). The FDA is also reviewing applications for approval of Glivec.

With these approvals Glivec is now indicated to treat four distinct types of cancer.