Novartis Drug Wins Expanded FDA Approval

A Novartis AG cancer drug has won expanded federal approval to treat five rare and potentially life-threatening diseases, the company said Thursday.

Gleevec, also called imatinib mesylate, may now be prescribed to treat dermatofibrosarcoma protuberans tumors, as well as four blood diseases: Philadelphia chromosome-positive acute lymphoblastic leukemia, hypereosinophilic syndrome, aggressive systemic mastocytosis and certain forms of myeloproliferative disorders.

Novartis, based in Switzerland, said there have been few if any approved treatments specific to the diseases available for many patients.

The Food and Drug Administration previously approved Gleevec to treat Philadelphia chromosome-positive chronic myeloid leukemia and gastrointestinal stromal tumors.

Also Friday, the FDA said Novartis was updating Gleevec's label with a precaution that describes the occasional occurrence of severe congestive heart failure and left ventricular dysfunction in patients on the drug.

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Food and Drug Administration: http://www.fda.gov/