Re: Breakthrough Designation
in response to
by
posted on
May 28, 2020 02:36PM
Note the projected 'goal date' statement from that November 2019 press release,
"....and granted Breakthrough Therapy Designation for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. The FDA granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of March 10, 2020."