FDA Sets Priority Status for Tasigna Review

18 February 2010 (Last Updated February 18th, 2010 18:30)

The US Food and Drug Administration (FDA) has granted priority review status to Novartis's Tasigna which, if approved, will be the first new treatment for patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML). FDA priority review status acceler

The US Food and Drug Administration (FDA) has granted priority review status to Novartis's Tasigna which, if approved, will be the first new treatment for patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML).

FDA priority review status accelerates the standard review time for a drug from ten to six months and is granted to potential therapies that offer major advances in treatment or for drugs that fill an unmet need.

Recent trials showed that fewer patients taking Tasigna progressed to more advanced stages of the disease than patients on the indicated treatment Gleevec at 12 months.

Tasigna also showed a statistically significant improvement over Gleevec in every other measure of efficacy in the trial, including major molecular response and complete cytogenetic response at 12 months.

Novartis Pharmaceuticals Division CEO David Epstein said that recently presented data showed that Tasigna surpassed Gleevec in every measure of treatment efficacy.

"This priority review designation brings us one step closer to offering patients with newly diagnosed Ph+ CML in the chronic phase a promising new treatment option," Epstein said.

In addition to the US, regulatory submissions have been filed in the EU and Japan.