Novartis announces European approval for Tasigna

Novartis has announced that the European Union has approved its new anti-cancer therapy Tasigna for use in patients with a life-threatening form of leukaemia who are resistant to prior treatment including Gliveca.

The European commission approved the therapy for use in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML).

David Epstein, president and chief executive office of Novartis Oncology, described the decision as an “opportunity” for the company to help more CML patients and allow Tasigna to be used with Glivec to provide comprehensive treatment options for prescribers.

“Tasigna drives home our commitment to develop compounds to fulfil unmet medical needs by pursuing indications for patients with limited treatment options,” he said.

The approval was supported by data showing that Tasigna produced a positive response in 49 per cent of patients with CML, with most patients achieving this response within three months of treatment.

Tasigna was approved by the US Food and Drug Administration in October 2007, based on the same clinical trial that supported the EU filing.

Last month, Novartis confirmed that Aclasta (zoledronic acid 5 mg) had received approval for use in the European Union as a once-yearly treatment for women with postmenopausal osteoporosis.