Novartis receives CHMP backing for leukaemia treatment
28 September 2010 00:00 in Pharmaceutical Company Product News
Novartis has been granted a recommendation from the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) for a new treatment for leukaemia.
The CHMP has endorsed the drug Tasigna to be approved in the EU as a first-line therapy for newly-diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia, based on positive data from clinical trials.
During a recent phase III study, the drug was compared to the alternative treatment Glivec and proved to offer superior performance in producing major molecular and complete cytogenetic response, as well as in delaying cancer progression.
The treatment has already been approved for this indication by regulatory authorities in the US and Switzerland.
Alessandro Riva, global head of oncology development and medical affairs at Novartis Oncology, said: "Following this positive opinion from CHMP, we look forward to working with regulatory authorities to bring Tasigna to clinical use in the first-line setting as soon as possible."
Earlier this month, Novartis published clinical data for SOM230, a new treatment for Cushing's disease which is the first of its kind to demonstrate efficacy in a phase III trial.
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