BRIEF—Breakthrough Therapy designation for Debiopharm

The US regulator has granted Breakthrough Therapy designation for Debiopharm's novel chemo-radio sensitizer Debio 1143, for first-line head and neck cancer.

The decision was based on Phase II data, presented in September 2019 at the annual European Society for Medical Oncology congress.

Chief development officer Angela Zubel said: "Despite today's current standard of care, high-risk locally-advanced head and neck cancer remains an area of unmet medical need. This Breakthrough Therapy Designation will allow us to maximize the potential of Debio 1143 to become an innovative radio-chemo enhancing treatment for LA-SCCHN patients.”

There have been no new therapies for people with "high risk" locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) in the last 25 years.