Nanobiotix amends Phase 3 cancer trial protocol to speed up final analysis and potential drug approval.

Nanobiotix announced that the FDA accepted a protocol amendment for its global Phase 3 NANORAY-312 study in head and neck cancer, submitted by Johnson & Johnson. The amendment removes the interim analysis and advances the final analysis to occur sooner with fewer events required. This change could accelerate the regulatory approval and commercialization of JNJ-1900 (NBTXR3), a novel cancer treatment activated by radiotherapy. Nanobiotix expects the final results to be available around the same time as the originally planned interim analysis, potentially enabling earlier revenue generation from milestone payments under its license agreement with Johnson & Johnson.