Supplemental approval of Opdivo + cisplatin + gemcitabine for treatment of unresectable urothelial carcinoma in Japan.-Ono Pharma

Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb K.K.  announced that Ono has received a supplemental approval of Opdivo (generic name: nivolumab) Intravenous Infusion (“Opdivo”), an anti-PD-1 antibody, in combination with cisplatin and gemcitabine for the treatment of unresectable urothelial carcinoma in Japan. This approval is related to the additional indication for a partial change in approved items of the manufacturing and marketing approval in Japan.

This approval is based on the results from the global, multi-center Phase III CheckMate -901 clinical trial (CA209-901/ONO-4538-56), evaluating Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy compared to standard-of-care chemotherapy alone, in patients with untreated, unresectable or metastatic urothelial carcinoma. In this study, Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy demonstrated statistically significant improvements in the primary efficacy endpoints of overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) compared to cisplatin and gemcitabine alone. The safety profile of Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy was consistent with the known safety profiles of the combination with chemotherapy and Opdivo monotherapy. No new safety concerns were identified.

 With respect to the indication of urothelial carcinoma, Opdivo was approved in Japan for the adjuvant treatment of eligible patients with urothelial carcinoma as a monotherapy in March 2022.