Bennet-Authored Breakthrough Designation Yields Full FDA Approval for Lung Cancer Drug

Novartis’ Zykadia Approved for Late-Stage Lung Cancer

Sixth Breakthrough Drug to Gain Wide Approval

Colorado U.S. Senator Michael Bennet welcomed the U.S. Food and Drug Administration’s (FDA) approval of another breakthrough drug – this time for a lung cancer drug manufactured by Novartis. The drug, known as Zykadia, will help treat patients with a certain type of late-stage non-small cell lung cancer.

The breakthrough designation stems from a provision authored by Bennet and Senators Orrin Hatch and Richard Burr in the 2012 FDA Safety and Innovation Act. The provision allows for expedited FDA approval for certain lifesaving drugs or treatments that show dramatic responses early in development, while still ensuring drug safety and efficacy.

“We’re already seeing the first breakthrough drugs and treatments improve the lives of patients in Colorado and throughout the country,” Bennet said. “Now we have yet another drug that can potentially save hundreds of thousands of lives. Innovation is happening at a blistering pace, and the ability to get these groundbreaking drugs to patients more quickly, and in a safe and responsible manner, allows us to help keep pace with that innovation.”

To date, the FDA has granted 44 breakthrough designations. Of those, six have gone on to receive FDA approval.