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 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.
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.