FDA grants fast track designation to RRx-001 for severe oral mucositis in head and neck cancer
Source: www.onclive.com Author: Chris Ryan The FDA has granted a fast track designation to RRx-001 for the prevention and attenuation of severe oral mucositis associated with chemotherapy and radiation in patients with head and neck cancer, according to a news release from EpicentRx.1 RRx-001, a direct NLRP3 inhibitor and Nrf2 upregulator with anti-inflammatory and antioxidant properties, is also under investigation for the treatment of small cell lung cancer. “The fast track designation is great news for EpicentRx, and it puts us one step closer to a potential treatment for this critical unmet need of oral mucositis with RRx-001,” Tony Reid, MD, PhD, chief executive officer of EpicentRx, stated in a news release. Investigators previously evaluated RRx-001 in the phase 2a PREVLAR trial (NCT03515538). The study evaluated the agent’s efficacy and feasibility in mitigating severe oral mucositis in patients with head and neck cancers who were receiving chemoradiation.2 Findings showed that in patients who experienced severe oral mucositis in the 3 RRx-001 treatment arm, the median duration of severe oral mucositis was 8.5 days, 17 days, and 10 days, in arms 1, 2, and 3 respectively, compared with 24 days in the control arm. When accounting for patients who did not experience severe oral mucositis, the median duration of severe oral mucositis was 5 days for patients in arm 1, 13.5 days for arm 2, 8 days in arm 3, and 18 days in the control arm. The trial enrolled patients at least 18 years of age with pathologically diagnosed stage [...]