The EU approval of Tasigna was based on a pivotal clinical trial evaluating the rates of cytogenetic response (reduction or elimination of the Philadelphia chromosome) and confirmed hematologic response (normalization of white blood cell counts) in Glivec-resistant or -intolerant patients with Ph+ chronic myeloid leukemia (CML) in chronic and accelerated phase.
Tasigna produced a positive response in 49% of patients in the chronic phase of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in a Phase III trial. Most patients achieved this response within three months of starting Tasigna treatment. Tasigna was designed to target the Bcr-Abl protein more preferentially than Glivec without adding new mechanisms of action.
The European Commission decision applies in all 27 EU member states plus Norway and Iceland, and follows recent approvals in the US and Switzerland. Tasigna is now approved in a total of 37 countries, and was also submitted for approval in Japan in June.
David Epstein, president and CEO of Novartis Oncology, said: “The approval of Tasigna gives us the opportunity to help more CML patients and, with Glivec as our first-line agent, provide comprehensive treatment options for prescribers.”