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 needs.

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 [e-mail]

(END) Dow Jones Newswires

10-04-22 0840ET