ZURICH, Feb 19 (Reuters) - Novartis AG’s NOVN.VX cancer drug Tasigna has won priority review by the U.S. Food and Drug Administration for newly diagnosed patients with early-stage chronic myeloid leukemia, the Swiss drugmaker said on Friday.
The priority review, which cuts the standard review time to six months from 10, comes after a study showed Tasigna exceeded Novartis’ Glivec in all measures of efficacy, including prevention of disease progression at 12 months.
Novartis is relying on Tasigna to replace sales of Glivec, a daily tablet also sold as Gleevec, which is its second biggest seller but loses patent protection over the next few years.
If Tasigna is approved it will the first treatment since Glivec for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia patients in chronic phase, Novartis said.
The group said regulatory applications had also been filed in Europe and Japan.
Reporting by Katie Reid