Posted by Michael Wonder on 27 Nov 2023
ONO receives supplemental approval of Opdivo in Japan for expanded use for treatment of malignant mesothelioma (excluding malignant pleural mesothelioma)
24 November 2023 - Ono Pharmaceutical today announced that ONO has received supplemental approval of Opdivo (nivolumab) intravenous infusion, a human anti-human PD-1 monoclonal antibody in Japan, for expanded use for the treatment of malignant mesothelioma (excluding malignant pleural mesothelioma), for a partial change in approved items of the manufacturing and marketing approval.
This approval is based on the result from the investigator-initiated clinical trial (VIOLA trial), conducted under the leadership of the Hyogo Medical University Hospital, in 20 patients with malignant mesothelioma (excluding malignant pleural mesothelioma).
