FDA grants fast track designation to Debio 1347 for FGFR-mutated tumors
The FDA granted fast track designation to Debio 1347 for the treatment of patients with unresectable or metastatic tumors with specific FGFR gene alterations, according to a company-issued press release.
Debio 1347 (CH5183284, Debiopharm International) is an FGFR1, FGFR2 and FGFR3 inhibitor.
The FDA based this designation on preliminary safety and efficacy data from a phase 1 open-label, multicenter study of Debio 1347 for in patients with advanced solid malignancies whose tumors have an alteration of the FGFR1, FGFR2 or FGFR3 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.” Peggy Lipp, director of regulatory affairs, market intelligence and market access at Debiopharm International, said in a company-issued press release. “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.”