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Leading Scientific Discovery
The Novartis Oncology pipeline holds a broad stream of promising future products, including new molecular agents for targeted therapy. Additional indications for marketed products are also being pursued. Novartis’ pioneering work in the field of targeted therapies continues with the development of the next generation of signal transduction inhibitors, including nilotinib, a new investigational agent being studied for CML patients intolerant of or resistant to Glivec®. Nilotinib was specifically designed to selectively inhibit Bcr-Abl. Discovered in the biomedical research facilities of Novartis, nilotinib (formerly AMN107) entered Phase I clinical studies in 2004, just 21 months after it was first synthesized in August 2002. Preclinical studies showed that nilotinib was active against wild-type, or nonmutant, Bcr-Abl, as well as 32 of 33 Bcr-Abl mutants most frequently associated with varying degrees of resistance to Glivec. In clinical trials to date, nilotinib eliminated or significantly reduced the presence of blood cells containing the Ph chromosome in approximately half of adult patients with CML who developed resistance or intolerance to treatment with Glivec®. Nilotinib has been recently filed in the United States and Europe for regulatory review. |
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See European Summary of Product Characteristics Glivec® 100 mg film coated tablets (PDF) Glivec® 400 mg film coated tablets (PDF) Glivec® 50 mg capsules, hard (PDF) Glivec® 100 mg capsules, hard (PDF)
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