CHMP recommends approval of change of authorisation for Tasigna (nilotinib) in Philadelphia chromosome positive chronic myelogenous leukaemia.- Novartis.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Tasigna (nilotinib), from Novartis. The CHMP adopted an extension to the existing indication as follows: paediatric as well as adult patients, with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, plus paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.

The drug is already indicated for adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.