Novartis drug Tasigna recommended for approval in European Union for newly diagnosed Ph+ chronic myeloid leukemia

28-Sep-2010 - Switzerland

Novartis has received a positive opinion recommending European Union approval of Tasigna® (nilotinib), a selective targeted therapy for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

The Committee for Medicinal Products for Human Use (CHMP) recommended approval of Tasigna in the first-line indication based on a pivotal Phase III clinical trial in which Tasigna surpassed Glivec® (imatinib) in key measures of treatment efficacy. In the study, Tasigna was found superior to Glivec in achieving higher rates of both major molecular and complete cytogenetic response and in delaying cancer progression. The 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 2010 annual meeting of the American Society of Clinical Oncology held in June.

"We are glad that the development of Tasigna may result in a potential new treatment option for newly diagnosed CML patients seeking effective means of preventing disease progression," said Alessandro Riva, Global Head, Oncology Development & Medical Affairs, Novartis Oncology. "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."

The European Commission generally follows the recommendations of the CHMP and delivers its final decision within three months. The decision will be applicable to all 27 European Union (EU) member states plus Iceland and Norway. In total, approximately 46,000 people in the EU are affected by CML, a life-threatening blood cancer.

The US Food and Drug Administration (FDA) and Swiss health authority Swissmedic have already approved Tasigna for newly diagnosed Ph+ CML. Regulatory submissions are also under way in Japan and worldwide.

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