Chugai Pharmaceutical has received regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the additional indication of neurofibromatosis type 2 (NF2) for the anti-cancer agent/humanised anti-VEGF monoclonal antibody Avastin Intravenous Infusion 100 mg/4 mL and 400 mg/16 mL [generic name: bevacizumab (genetical recombination)]. Avastin is the first drug approved in the world for the treatment of this disease.

Dr. Osamu Okuda, President and CEO, Chugai Pharmaceutical, said, “We are very pleased to deliver Avastin as the world’s first therapeutic drug for neurofibromatosis type 2 in Japan. NF2 is a rare disease that causes symptoms such as hearing loss and dizziness, significantly impacting patients’ daily lives, and there has been a strong need for effective treatment options. Avastin represents a new therapeutic option, suggesting potential for the maintenance or improvement of hearing and a trend toward tumor reduction. We will continue our efforts to promptly provide appropriate use information so that we can contribute to patient treatment and improvement in quality of life.”

This approval is based on the results from the investigator-initiated Japanese phase 2 clinical study, the BeatNF2 study, which evaluated the efficacy and safety of Avastin in NF2.