PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Regulatory News: NANOBIOTIX (Paris:NANO) (Euronext: NANO - ISIN: FR0011341205 – the “Company”), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced that the U.S. Food and Drug Administration (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.
Fast Track is a process designed to facilitate the development and accelerate the review of drugs for serious conditions and that have the potential to address unmet medical needs. The purpose is to expedite the availability of new treatment options for patients.
A product that receives Fast Track designation is eligible for1:
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More frequent meetings with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from the FDA about such things as the design of proposed clinical trials and the use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of the New Drug Application (NDA) for review by the FDA, rather than waiting until the entire NDA is completed before the application can be reviewed
NBTXR3 is a first-in-class product designed to destroy tumors 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. The physical mode of action of NBTXR3 makes it applicable across solid tumors such as lung, prostate, liver, glioblastoma, and breast cancers.
NBTXR3 is actively being evaluated locally advanced head and neck squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx in elderly and frail patients unable to receive chemotherapy or cetuximab with limited therapeutic options. Promising results have been observed in the phase I trial regarding local control. In the United States, the company has started the regulatory process for the clinical authorization of a phase II/III trial in locally advanced head and neck cancers.