www.fdanews.com/articles/196077-japan-approves-opdivo-for-unresectable-advanced-or-recurrent-esophageal-cancer
Japan Approves Opdivo for Unresectable Advanced or Recurrent Esophageal Cancer
March 2, 2020
Japan’s Ministry of Health, Labor, and Welfare approved Bristol-Myers Squibb’s Opdivo (nivolumab) for patients with unresectable advanced or recurrent esophageal cancer that has progressed following chemotherapy.
The approval was supported by the results of a phase 3 clinical trial in which Opdivo demonstrated a 23 percent reduction in the risk of death and a 2.5-month improvement in median overall survival compared with chemotherapy.
Opdivo is currently approved in more than 65 countries, including thirteen approved indications in the U.S.