Ono Pharmaceutical Co., Ltd...and Bristol-Myers Squib...today announced that ONO has received the approvals of Opdivo® (generic name: nivolumab) Intravenous Infusion (“Opdivo”), a human anti-PD-1 monoclonal antibody in Japan, for expanded use for the first-line treatment of unresectable advanced or recurrent gastric cancer in combination with chemotherapy, and adjuvant treatment of esophageal cancer...

OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of...patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy.

Bristol-Myers Squibb Company (NYSE:BMY) today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Opdivo (nivolumab) for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy. 

Consistent with results from the global primary analysis of CheckMate 649, nivolumab plus chemotherapy demonstrated a clinically meaningful improvement in OS and PFS and higher response rate vs chemotherapy and an acceptable safety profile in Chinese patients. Nivolumab plus chemotherapy represents a new standard first-line treatment for Chinese patients with non-HER2-positive advanced GC/GEJC/EAC.

...we report the 3-year follow-up data of the ATTRACTION-2 study and a subset analysis of postprogression survival (PPS) after the first event of PD in all patients who received TBP in the nivolumab...unresectable advanced or recurrent G/GEJ cancer histologically confirmed to be adenocarcinoma...At the 3-year follow-up, the median OS (95% CI) in the nivolumab group (5.26 [4.60–6.37] months)...Median PFS (95% CI) was 1.61 (1.54–2.30) months in the nivolumab group...The long-term efficacy of nivolumab was confirmed throughout the 3-year follow-up period in the ATTRACTION-2 study...

Bristol Myers Squibb...today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC), based on results from the CheckMate -649 trial. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 25, 2021.

Median overall survival was 5·26 months (95% CI 4·60-6·37) in the nivolumab group and 4·14 months (3·42-4·86) in the placebo group (hazard ratio 0·63, 95% CI 0·51-0·78; p<0·0001)...12-month overall survival rates were 26·2% (95% CI 20·7-32·0) with nivolumab and 10·9% (6·2-17·0) with placebo....the survival benefits indicate that nivolumab might be a new treatment option for heavily pretreated patients with advanced gastric or gastro-oesophageal junction cancer.