Posted by Michael Wonder on 31 Mar 2022
Ono receives supplemental approval of Opdivo (nivolumab) for adjuvant treatment of urothelial carcinoma in Japan
28 March 2022 - Ono Pharmaceutical today announced that Ono has received a supplemental approval of Opdivo (nivolumab) in Japan for the adjuvant treatment of urothelial carcinoma, for a partial change in approved items of the manufacturing and marketing approval.
This approval is based on the results from the global multi-centre, randomised, double-blind Phase 3 CheckMate-274 study (ONO-4538-33), evaluating Opdivo monotherapy compared to placebo as an adjuvant treatment in patients with muscle-invasive urothelial carcinoma at a high risk of recurrence after radical surgery.
