FDA grants breakthrough therapy designation for Debiopharm's novel chemo-radio sensititiser Debio 1143 for front-line treatment of head & neck cancer


27 February 2020 - The FDA decision was based on the compelling magnitude of the clinically phase II findings in combination with chemo-radiotherapy presented in September 2019 at the ESMO congress.

Debiopharm today announced that the American 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). 

Ongoing clinical investigations have been developed to evaluate the benefit of increasing tumor cell sensitivity to CRT, making the addition of Debio 1143 a highly promising strategy for radio-oncologists to improve treatment outcomes for high-risk LA-SCCHN.

Read Debiopharm press release

Michael Wonder

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Michael Wonder