The Swiss drugmaker is studying LDK378 as a treatment for a rare type of metastatic non-small cell lung cancer. It is intended for patients whose cancer progressed during treatment with Pfizer Inc.'s drug Xalkori, or who could not tolerate treatment with Xalkori.
The FDA created the breakthrough therapy program in 2012 as a way to speed up the approval process for drugs that could be significant improvements in the treatment of serious or life-threatening diseases from what's currently on the market.
Novartis is running two mid-stage clinical trials of LDK378. It plans to start late-stage testing later in 2013 and to file for marketing approval in early 2014.
Shares of Novartis rose 96 cents to $69.91 in late morning trading. The stock has changed hands between $51.20 and $70.24 in the past 52 weeks.