Novartis gains EU approval for Tasigna in new Ph+ CML patients; files Bexsero MAA

Novartis (NOVN: VX) said yesterday that it has 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. A similar clearance was granted by the US Food and Drug administration earlier this year (The Pharma Letter June 18) and the drug has also gained approval in Japan (TPL December 22) and Switzerland, with other submissions under review.

The EC approval 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, Novartis own drug Glivec/Gleevec (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.

"We are pleased that Tasigna is now approved for newly-diagnosed Ph+ CML patients in chronic phase in the member states of the European Union," said Herve Hoppenot, president of Novartis Oncology. "With this expanded indication, newly-diagnosed patients can benefit from a Bcr-Abl tyrosine kinase inhibitor that, according to pivotal data, surpassed the standard of care Glivec, in key measures of efficacy, including delaying disease progression at 12 months," he added.