Posted by Michael Wonder on 28 Mar 2023
Ono receives supplemental approval of Opdivo in combination with chemotherapy for neo-adjuvant treatment of non-small-cell lung cancer in Japan
27 March 2023 - Ono Pharmaceutical and Bristol-Myers Squibb today announced that Ono Pharmaceutical has received a supplemental approval of Opdivo (nivolumab) intravenous infusion, a human anti-human PD-1 monoclonal antibody in Japan for the neo-adjuvant treatment of non-small-cell lung cancer in combination with chemotherapy, for a partial change in approved items of the manufacturing and marketing approval.
This approval is based on the results from a global multi-center, randomised, open-label Phase 3 clinical trial, CheckMate-816 trial (ONO-4538-55), evaluating Opdivo in combination with chemotherapy compared to chemotherapy alone as a neo-adjuvant treatment in patients with resectable non-small-cell lung cancer.
