Nanobiotix Amends Protocol for Phase 3 Head and Neck Cancer Study
Biotechnology firm Nanobiotix announced FDA acceptance of a protocol amendment to its ongoing global Phase 3 study for head and neck cancer. The change may accelerate the drug approval pathway.
Biotechnology company Nanobiotix announced on May 4, 2026, that the U.S. Food and Drug Administration (FDA) has accepted a protocol amendment for its ongoing global Phase 3 NANORAY-312 study. The study is investigating a physics-based treatment for head and neck cancer.
The amendment eliminates the previously planned interim analysis and modifies the final analysis to occur sooner and include fewer events than originally intended. Nanobiotix stated that this change could accelerate the registration pathway for its drug candidate, JNJ-1900 (NBTXR3), and potentially lead to earlier revenue generation.
The study, sponsored by Johnson & Johnson and conducted under a license agreement with Janssen Pharmaceutica NV, utilizes hafnium oxide nanoparticles that are activated by radiotherapy. Nanobiotix believes this approach is scalable across various solid tumors and can be combined with other cancer therapies.
The company anticipates the modified final analysis readout within the same timeframe as the originally planned interim analysis, depending on the timing of clinical events. Under the existing license agreement, Nanobiotix is eligible for significant milestone payments upon the achievement of further development and regulatory objectives.