FDA-approved cancer drug gets revised label, better results with prolonged use

The U.S. Food and Drug Administration has approved a revised label for cancer drug Gleevec following a clinical study that showed better results with prolonged use of the drug compared with the 12 months that has been recommended.

The U.S. regulator also granted regular approval of Gleevec. Marketed by Swiss pharmaceutical company Novartis Pharmaceuticals (NYSE:NVS) with U.S. headquarters in East Hanover, New Jersey, the drug was approved for use in 2008 for patients with gastrointestinal stromal tumors, a rare form of cancer, under the FDA’s accelerated approval program. The program gives earlier patient access to promising new drugs even as confirmatory clinical trials are taking place.

New data from a clinical study showed that patients with gastrointestinal cancer had better results when they took the drug for 36 months rather than 12 months.

The cancer drug made the cover of Time magazine in 2001 around the time it was first approved by the FDA to treat patients with advanced Philadelphia chromosome positive chronic myeloid leukemia, a blood and bone marrow disease linked to a genetic abnormality, the FDA statement said.

There are about 4,500 to 6,000 new cases of GIST reported each year. Most cases occur in people between 40 and 80 years of age, according to Novartis’ website.

The developers of Gleevec, Brian Druker and Nicholas Lydon, raised $40 million for their Cambridge, Massachusetts startup Blueprint Medicines in a series A round led by Third Rock Ventures in April last year.