Guest guest Posted April 11, 2006 Report Posted April 11, 2006 Novartis seeks Gleevac OK in 4 cancers NEW YORK, April 10 (UPI) -- Novartis is seeking approval in the United States and Europe to market cancer drug Gleevac for four additional cancer types. According to a report Monday in the Wall Street Journal, Novartis has filed for approval with the Food and Drug Administration and with European regulators for expanded use of Gleevac to treat a skin cancer known as dermatofibrosarcoma protuberans; and three blood cancers, hypereosinophilic syndrome, systemic mastocytosis and certain types of myeloproliferative disorders, the WSJ report said. Gleevac is currently approved to treat chronic myeloid leukemia and a type of stomach cancer known as GIST, the report said. Because the cancers for which Novartis is seeking additional approval are so rare, the company was unable to study Gleevac in thousands of patients as the FDA normally requires, but instead has submitted data from a series of small clinical trials conducted by the Swiss drug company and by independent researchers. Novartis' latest filings reflect a shift in how cancer should be treated, based on the belief that there are " hundreds of subgroups of cancer based more on genetic makeup than on location, " the WSJ reported. Thus, cancer treatment is starting to emphasize the genetic mutations involved in a specific cancer case, rather than on the organ in which the cancer is located, the report said. Quote
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