Posted by Michael Wonder on 11 Feb 2020
Nanobiotix announces fast track designation granted by U.S. FDA for investigation of first-in-class NBTXR3 in head and neck cancer
10 February 2020 - The U.S. FDA reviewed the Company’s request for fast track designation and concluded that investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy.
Nanobiotix today announced that the U.S. FDA has granted fast track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy.
NBTXR3 is a first-in-class product designed to destroy tumours through physical cell death when activated by radiotherapy. NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide radiotherapy radiation therapy standards of care.
