FDA Grants Breakthrough Status to J&J Head and Neck Cancer Candidate; TREMFYA® Achieves 80%+ Remission at Week 140
Johnson & Johnson's investigational antibody-drug conjugate for advanced head and neck cancer received FDA Breakthrough Therapy designation, expediting its review. TREMFYA® sustained remission through Week 140 in ulcerative colitis, with over 80% clinical remission, more than 50% endoscopic remission and 78% histo-endoscopic mucosal improvement.
1. Breakthrough Designation for Head and Neck Cancer Candidate
The FDA granted Breakthrough Therapy designation to J&J’s investigational antibody-drug conjugate for advanced head and neck cancer, highlighting its potential to address significant unmet needs. This status provides priority review and rolling submission privileges, potentially accelerating clinical development and regulatory approval timelines.
2. TREMFYA® Sustains Remission in Ulcerative Colitis Through Week 140
Data from the QUASAR long-term extension study demonstrated TREMFYA® maintained clinical, endoscopic and histologic remission through Week 140 in adults with moderately to severely active ulcerative colitis. More than 80% of patients achieved clinical remission, over 50% endoscopic remission and 78% histo-endoscopic mucosal improvement, reinforcing TREMFYA®’s role in long-term disease management.