Novartis received approval from the European Commission for Tasigna® (nilotinib) as a treatment for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The approval from the European Commission followed a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). It is based on findings from a pivotal Phase III trial demonstrating superiority to the standard of care Glivec® (imatinib)* in achieving molecular and cytogenetic response and delaying cancer progression. These data were first published in the June 17 issue of The New England Journal of Medicine[1] and were confirmed by 18-month median follow-up data presented at the 46th American Society of Clinical Oncology (ASCO) annual meeting held in June[2].
The US Food and Drug Administration (FDA), Swissmedic and Japan’s Ministry of Health, Labour and Welfare have also approved Tasigna in this first-line indication. Regulatory submissions are under review in other countries worldwide.
