Bristol-Myers Squibb Release: Japan Ministry Of Health, Labor And Welfare Approves Opdivo (Nivolumab) For The Treatment Of Patients With Unresectable Advanced Or Recurrent Gastric Cancer Which Has Progressed After Chemotherapy
Opdivo is the first and only Immuno-Oncology treatment to demonstrate survival benefit in patients who underwent two or more prior treatments
Opdivo is the first Immuno-Oncology agent anywhere in the world to receive approval for unresectable advanced or recurrent gastric cancer based on a Phase 3 study
PRINCETON, N.J.--(BUSINESS WIRE)--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. This approval was based on the Phase 3 study ATTRACTION-2 (ONO-4538-12), in which Opdivo significantly reduced patients’ risk of death by 37% (HR 0.63 [95% CI: 0.51-0.78, p<0.0001]) when compared to placebo. Furthermore, Opdivo demonstrated a greater overall survival rate at 12 months versus placebo, 26.2% (95% CI: 20.7-32.0) and 10.9% (6.2-17.0), respectively. The safety profile of Opdivo in this study was consistent with previously reported studies in solid tumors, and discontinuation rates due to treatment-related adverse events (TRAEs) in the Opdivo and placebo arms were comparable.
“The approval of Opdivo for advanced or recurrent gastric cancer in Japan offers healthcare providers and patients a much-needed new treatment option, and reinforces our commitment to advance the treatment of cancer through Immuno-Oncology based approaches,” said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb. “Opdivo has now been approved for six indications in Japan, underscoring the success of the Ono Pharmaceutical and Bristol-Myers Squibb partnership and our shared commitment to delivering innovative medicines to patients and advancing cancer care in Japan and around the world.”
The prevalence of gastric cancer is highest in Asian countries, and it is the second most common cancer diagnosis in Japan, with nearly 134,000 people diagnosed in 2016. While treatment options are available for patients in earlier lines of therapy, nearly all patients with advanced gastric cancer continue to experience disease progression, reinforcing the need for innovative new treatment options.