Novartis' Tasigna receives priority review from FDA

EAST HANOVER, N.J. The Food and Drug Administration will shorten its review time of a Novartis drug under investigation as a treatment for leukemia, Novartis said Friday.

The agency plans to give priority review to Tasigna (nilotinib) for the treatment of adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia, also known as Ph+ CML, in the disease’s chronic phase. The FDA grants priority review to drugs that it considers to offer major advances in treatment or to provide treatment where no adequate therapy exists, accelerating the standard review time from 10 months to six.

Novartis said that in clinical trials, Tasigna stopped Ph+ CML from progressing to more advanced stages in “significantly” more patients than did the standard of  care, Gleevec (imatinib mesylate), also made by Novartis.

“Recently presented data showed that Tasigna surpassed Gleevec in every measure of treatment efficacy designated in the study, including prevention of disease progression at 12 months,” Novartis Pharmaceuticals Division CEO David Epstein said. “Now, this priority review designation brings us one step closer to offering patients who are newly diagnosed with Ph+ CML in the chronic phase a promising new treatment option.”