Novartis' moves closer to EU approval with positive CPMP opinion onGlivec
The European Medicines Evaluation Agency's Committee for Proprietary Medicinal Products has given Novartis a positive opinion for its Glivec (imatinib; known as Gleevec in the USA) for the treatment of adult patients with Philadelphia chromosome (bcr-acl) positive chronic myeloid leukemia in chronic phase after interferon-alfa therapy had failed, as well as in accelerated phase or blast crisis.
Novartis' application for marketing authorization was based on previous Phase I and Phase II data from a 1000-patient global clinical trials program, which demonstrated that a near-complete, durable hematologic response was achieved in more than 90% of patients, with more than 50% seeing a half or complete disappearance of the Philadelphia chromosome in bone marrow. Patients in accelerated phase had continued high levels of responses, with good cytogenetic response rates for this population of patients. Blast-crisis patients continued to demonstrate rapid hematologic blood count responses which were sustained in nearly a third of responders.
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