Cue Biopharma Gets FDA Fast-Track Designation for CUE-101 in Head, Neck Cancer
By Colin Kellaher
Cue Biopharma Inc. on Tuesday said the U.S. Food and Drug
Administration granted fast-track designation to CUE-101, its lead
drug candidate, for certain head and neck cancers.
The Boston clinical-stage biopharmaceutical company said the
designation covers CUE-101 in patients with human papilloma virus
recurrent/metastatic head and neck squamous cell carcinoma, as a
monotherapy and in combination with Merck & Co.'s blockbuster
cancer drug Keytruda.
The FDA's fast-track program is designed to facilitate the
development and expedite the review of treatments for serious or
potentially life-threatening illnesses with high unmet medical
Cue said CUE-101 is being evaluated in a Phase 1b study as a
monotherapy for second-line and beyond patients and as a first-line
treatment in a Phase 1 dose-escalation and expansion trial in
combination with Keytruda.
Write to Colin Kellaher at firstname.lastname@example.org
(END) Dow Jones Newswires
October 04, 2022 08:40 ET (12:40 GMT)
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