FDA grants fast track designation to NBTXR3 for head and neck cancer
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The FDA granted fast track designation to NBTXR3, with or without cetuximab, for the treatment of patients with locally advanced head and neck squamous cell carcinoma who are not eligible for platinum-based chemotherapy, according to a company-issued press release.
NBTXR3 (Nanobiotix) — which includes an aqueous suspension of crystalline hafnium oxide nanoparticles to destroy tumors via cell death — is administered in a single dose prior to the first session of radiotherapy, which activates the treatment.
A phase 1 trial showed NBTXR3 induced promising rates of local control among elderly and frail patients with locally advanced HNSCC of the oral cavity or oropharynx who were unable to receive chemotherapy or cetuximab (Erbitux, Eli Lilly) and therefore had limited therapeutic options.
Nanobiotix also is planning a phase 2/phase 3 trial of NBTXR3 for locally advanced head and neck cancers. The company has received FDA approval to launch a trial of NBTXR3 in combination with anti-PD-1 antibodies for locoregional recurrent or recurrent and metastatic HNSCC and for lung or liver metastases from any primary cancer eligible for treatment with anti-PD-1.
Ongoing trials also are assessing NBTXR3 among patients with hepatocellular carcinoma or liver metastases, locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma. Further, nine phase 1/phase 2 trials are underway in collaboration with The University of Texas MD Anderson Cancer Center to assess NBTXR3 for head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers.
“The FDA’s decision to grant fast track designation is not only important for the development of NBTXR3 activated by radiation therapy, which is now eligible for accelerated approval and priority review, but even more critically it underscores the unmet needs and limited options of patients with locally advanced head and neck cancer,” Laurent Levy, CEO of Nanobiotix, said in the press release. “The available public data and our development plans moving forward give us confidence that NBTXR3 could significantly improve treatment outcomes for patients. Fast track development in head and neck cancer is a major step forward.”