Pivotal study showed drug was more effective than Gleevec at achieving molecular/cytogenetic response.

Japan’s regulatory authority has approved Novartis’ Tasigna® (nilotinib) for the treatment of adult patients with newly diagnosed Philadelpha chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. Clearance was granted on the basis of previously reported Phase III data demonstrating that Tasigna was more effective than the current standard of care, Gleevec® (imatinib), in terms of achieving molecular and cytogenetic response and delaying cancer progression.

Tasigna has previously been approved in the U.S. for the first-line therapy indication, but has not yet been sanctioned in the EU for this cohort of patients. Tasigna clearance in Europe has, however, been granted for the treatment of chronic phase and accelerated phase PH+ CML in adult patients who are resistant or intolerant to at least one prior therapy, including Glivec.

Novartis is separately collaborating with Cepheid to develop a Bcr-Abl test for use in the accurate monitoring of Ph+ CML patients. The firms also aim to develop a next-generation test that will in addition indicate the degree of response to tyrosine kinase inhibitors including Tasigna and Glivec. Novartis points out there is currently no FDA cleared assay for monitoring Bcr-Abl.

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