Novartis wins FDA nod for broader Tasigna use

Novartis has taken one step closer to making its cancer drug Tasigna a robust successor to its blockbuster treatment Gleevec. The FDA gave its blessing to Tasigna as a first-line treatment for a rare type of blood cancer. Previously the drug was only approved for use in a particular form of chronic myeloid leukemia, in patients who either couldn't tolerate or had stopped responding to other drugs, including Gleevec.

The OK comes after the agency gave priority review to the indication and is based on a "major molecular response" in 44 percent of Tasigna patients versus 22 percent for Gleevec users. "With the faster and deeper responses we are seeing with Tasigna, newly diagnosed chronic myeloid leukemia (CML) patients will have a new and more effective treatment option," Novartis' oncology chief Herve Hoppenot said in a statement. And with this new indication, Novartis will have the chance to boost Tasigna use in a big way.

Of course, there is a potential spoiler out there: The Bristol-Myers Squibb drug Sprycel. BMS is hoping to nab FDA approval for use in earlier stages of CML as well; in a recent head-to-head trial, Sprycel did manage to best Gleevec just as Tasigna did. So stay tuned.

- see the statement from Novartis
- read the FDA release
- get more from the Wall Street Journal
- check out the International Business Times coverage
- find the Reuters article