Novartis' Tasigna approved in Japan; JAK inhibitor INC424 meets primary Ph III endpoint

It was a god news day for Swiss drug major Novartis (NOVN: VX) yesterday, as it received approval from Japan's Ministry of Health, Labor and Welfare for Tasigna (nilotinib) as a treatment for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. It also announced positive Phase III trial results with its JAK inhibitor INC424.

The Japanese approval of Tasigna is based on positive findings from a pivotal Phase III trial demonstrating superiority to the standard of care Glivec (imatinib) in achieving molecular and cytogenetic response and delaying cancer progression. The US Food and Drug Administration and Swissmedic have also approved Tasigna in this first-line indication. Regulatory submissions are under review in other countries worldwide.

In laboratory studies, Tasigna has been shown to be a potent and selective inhibitor of the Bcr-Abl protein that causes production of cancer cells in Ph+ CML. It is also active against a broad spectrum of Bcr-Abl mutations associated with resistance to Glivec. In its pivotal head-to-head trial, Tasigna surpassed Glivec in key measures of treatment efficacy, as has been previously reported.