Posted by Michael Wonder on 09 May 2018
FDA grants fast track designation to Debiopharm's Debio 1347 for the treatment of patients with unresectable or metastatic tumours with a specific FGFR gene alteration
8 May 2018 - Debiopharm announced today that the U.S. FDA has granted fast track designation to Debio 1347, an FGFR 1-3 inhibitor, for the treatment of patients with unresectable or metastatic tumours with a specific FGFR gene alteration.
This designation is based on the preliminary efficacy and safety data collected in the phase I study under Investigational New Drug application (IND) of Debio 1347 for the treatment of patients with unresectable or metastatic tumors with a specific FGFR gene alteration.
The phase I is a gene alteration-based, open label, multicenter study of oral Debio 1347 (CH5183284) in patients with advanced solid malignancies, whose tumours have an alteration of the FGFR1, 2 or 3 genes.
