FDA gives Clovis drug 'breakthrough' status
Last Updated: 14:07 May 20, 2014
The drug, called CO-1686, is intended to treat lung cancer.
The breakthrough therapy designation was enacted as part of the 2012 FDA Safety and Innovation Act and aims to expedite development and review of drugs to treat life-threatening medical conditions when preliminary evidence suggests that the drug may result in substantial improvement over other therapies.
"This designation is well-timed for us as well, as the increased interaction with FDA that it provides will come as we are initiating our registration studies and preparing to submit our initial new drug application by mid-2015," said Patrick J. Mahaffy, president and CEO of Clovis Oncology, in a statement.
The achievement was hailed by U.S. Sen. Michael Bennet, D-Colo., who wrote the provision in the FDA Safety and Innovation Act that includes the breakthrough therapy designation.
"By accelerating the timeline for FDA approval, our Breakthrough Therapy provision is ensuring that innovative, lifesaving drugs get into the hands of patients that need them safely and faster than ever," Bennet said in a media release.
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