Feb 10, 2020: NANOBIOTIX , a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer announced that the U.S. FDA has granted Fast Track designation for the investigation of NBTXR3 activated by the radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced head and neck squamous cell cancer who are not appropriate for platinum-based chemotherapy.
Fast Track is a process designed in order to facilitate the development and accelerate the review of drugs for the serious conditions and that have the potential to address unmet medical needs. The purpose is to speed up the availability of new treatment options for the patients.
The products that receives Fast Track designation is eligible for :
• More frequent meetings with the FDA to examine the drug’s development plan and make sure about the collection of appropriate data needed to support drug approval.
• More numerous written communication from the FDA about such things as the design of the proposed clinical trials and the use of biomarkers.
• Eligibility for the Accelerated Approval and Priority Review, if relevant criteria are met.
• Rolling Review, which means that the drug company can submit completed sections of the NDA for review by the FDA, rather than waiting until the entire NDA is completed before the application can be reviewed
NBTXR3 NBTXR3 is a first-in-class product designed in order to destroy tumors through physical cell death when activated by the radiotherapy. It has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the capability to fit into current worldwide radiotherapy radiation therapy standards of the care.
https://www.nanobiotix.com/wp-content/uploads/2020/02/PR_ENGLISH-Fast-Track-Designation.pdf
