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Association details:
Biomarker:No biomarker
Cancer:Squamous Cell Carcinoma of Head and Neck
Drug:xevinapant (Debio 1143) (IAP antagonist)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

FDA grants breakthrough therapy designation for debiopharm’s novel chemo-radio sensitizer debio 1143 for front-line treatment of head & neck cancer

Published date:
02/27/2020
Excerpt:
Debiopharm…a Swiss-based, global biopharmaceutical company, today announced that the American Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for Debio 1143, the most clinically advanced IAP antagonist, for the treatment of patients with confirmed diagnosis of previously untreated, unresectable locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) in combination with current standard of care, cisplatin-based concomitant standard fractionation chemoradiation therapy (CRT).
Secondary therapy:
cisplatin