Debiopharm announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Debio 1347, an FGFR 1-3 Inhibitor, for the treatment of patients with unresectable or metastatic tumors with a specific FGFR gene alteration. The FDA's Fast Track designation facilitates the development of new therapies that treat serious conditions and fulfill an unmet medical need in an effort to get treatments to those in need sooner.
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 tumors have an alteration of the FGFR1, 2 or 3 genes.
"This Fast Track designation is an encouraging step in our innovative approach to advance the care of the patients with unresectable or metastatic tumors with a specific FGFR gene alteration, who have little or no other treatment options." said Peggy Lipp, Director, Regulatory Affairs, Market Intelligence & Market Access at Debiopharm International. "It is critical that we address the unmet medical need of these patients and we are looking forward to working with the FDA to accelerate the development of this potential therapy."