2020-11-24 07:01:11 BMY Bristol-Myers
11/24/20 11/2407:01 11/24/2007:01 | Bristol-Myers announces approval of Opdivo in EuropeBristol Myers Squibb announced that the European Commission, or EC, has approved Opdivo, or nivolumab, for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma, or ESCC, after prior fluoropyrimidine- and platinum-based combination chemotherapy. The EC's decision is based on results from the Phase 3 ATTRACTION-3 trial, a study sponsored by Ono Pharmaceutical of Japan, which demonstrated a statistically significant and clinically meaningful improvement in overall survival, or OS, in patients who received Opdivo versus chemotherapy. The safety profile for Opdivo was favorable compared with chemotherapy and consistent with previously reported studies of Opdivo in other solid tumors. In addition to this approval in the EU, Opdivo has been approved in five countries, including the U.S. and Japan, for the second-line treatment of patients with unresectable advanced, recurrent or metastatic ESCC. |
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