Novartis’ Tasigna given EU backing for chronic myeloid leukaemia

Novartis has received approval to market its drug Tasigna as a treatment for chronic myeloid leukaemia (CML) in Europe.

The European Commission has ratified the therapy for use among adult patients with newly-diagnosed Philadelphia chromosome-positive CML in the chronic phase, based on a recommendation from the Committee for Medicinal Products for Human Use.

Novartis has been granted the backing after submitting clinical trial data demonstrating Tasigna's superior performance to its older treatment Glivec, which is the current standard of care.

It comes after the drug also received approval in territories such as the US, Japan and Switzerland, while other regulatory submissions are pending approval.

Herve Hoppenot, president for Novartis Oncology, said: "With this expanded indication, newly-diagnosed patients can benefit from a Bcr-Abl tyrosine kinase inhibitor that … surpassed the standard of care Glivec in key measures of efficacy, including delaying disease progression at 12 months."

Earlier this month, Novartis submitted its new drug Bexsero, a vaccine for meningococcal B diseases, for approval in Europe.