Novartis leukaemia drug Tasigna approved in Japan

The approval was granted on the basis of a pivotal Phase III trial, in which Tasigna demonstrated superiority to the standard of care Glivec (imatinib) in achieving molecular and cytogenetic response and delaying cancer progression.

The randomised, open-label, multicentre trial was designed to compare the efficacy and safety of Tasigna versus Glivec in adult patients with newly diagnosed Ph+ CML in chronic phase.

The US Food and Drug Administration and Swissmedic have also granted approval for Tasigna in this first-line indication, and regulatory submissions are under review in other countries worldwide.

Novartis Oncology president Hervé Hoppenot said the approval of Tasigna for newly diagnosed Ph+ CML patients in chronic phase illustrates the Novartis commitment to continue challenging and advancing the science for treating cancer.

"Tasigna was developed because we believed we could improve upon the standard of care to meet patients’ unmet needs, and as a result, patients now have a new and effective option for the treatment of CML," Hoppenot said.