Tasigna Approved for CML

Following a priority review, Novartis received FDA approval for Tasigna 150 mg capsules for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML). With this approval, Tasigna becomes the first new treatment option for newly diagnosed patients since the introduction of Gleevec tablets.

The approval was based on results from a Phase III trial evaluating the efficacy and safety of Tasigna in newly diagnosed Ph+ CML patients. The trial measured the effectiveness of Tasigna is based on major molecular response and cytogenetic response rates. Tasigna is 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 Gleevec.

In its head-to-head trial against Gleevec, Tasigna demonstrated improved treatment efficacy and reduced Bcr-Abl faster than Gleevec, resulting in lower rates of cancer progression. Treatment with Tasigna also led to higher rates of both major molecular response and complete cytogenetic response (reduction in the level of Philadelphia chromosome that is the hallmark of this cancer) compared with Gleevec.

“With the faster and deeper responses we are seeing with Tasigna, newly diagnosed CML patients will have a new and more effective treatment option,” said Herve Hoppenot, president, Novartis Oncology.