FDA grants breakthrough therapy designation to Debio 1143 for head and neck cancer
The FDA granted breakthrough therapy designation to Debio 1143 for first-line treatment of head and neck cancer, according to the agent’s manufacturer.
The designation applies to use of Debio 1143 (Debiopharm) — a novel inhibitor of apoptosis proteins antagonist — in combination with standard cisplatin-based concomitant standard fractionation chemoradiation for patients with previously untreated, unresectable locally advanced head and neck squamous cell carcinoma.
The FDA based the designation on results of a phase 2 study that showed the combination of Debio 1143 and chemoradiation improved locoregional control by 21% at 18 months and improved 2-year PFS (HR = 0.37; P = .007) compared with placebo plus chemoradiation.
The agent also exhibited a manageable safety profile.
No new therapies have been approved in the past 25 years for patients with locally advanced head and neck squamous cell carcinoma.
“Despite today’s current standard of care, high-risk locally advanced head and neck cancer remains an area of unmet medical need,” Angela Zubel, chief development officer of Debiopharm, said in a company-issued press release. “This breakthrough therapy designation will allow us to maximize the potential of Debio 1143 to become an innovative radiochemo-enhancing treatment for [this patient population].”