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news.Novartis's Tasigna has been approved in the US as a new anticancer therapy for a form of leukemia in patients who are resistant or intolerant to prior treatment including Glivec, another Novartis medicine.
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Novartis said that it will supply Tasigna throughout the US within days following this approval to meet the treatment needs of these patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).
This approval is based on an open-label multicenter clinical trial evaluating the drug’s safety and rates of cytogenetic response (i.e. reduction or elimination of the Philadelphia chromosome) and hematologic response (i.e. normalization of white blood cell counts) in Glivec-resistant or intolerant patients with Ph+ CML in chronic phase (n=280) and accelerated phase (n=105).
David Epstein, president and CEO of Novartis oncology, said: “Tasigna represents an important advance for the small number of patients who are resistant or intolerant to prior therapy. This approval means we can offer physicians a comprehensive treatment approach with effective medicines to treat their Ph+ CML patients.”