U.S. Food and Drug Administration Approves Opdivo? (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma, Regardless of PD-L1 Expression Status

發(fā)布時間： 2021-04-23 閱讀：822次

分享

April 16, 2021—Bristol Myers Squibb today announced that Opdivo (nivolumab) (injection for intravenous use), in combination with fluoropyrimidine- and platinum-containing chemotherapy, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, regardless of PD-L1 expression status.

“In CheckMate -649, Opdivo plus chemotherapy combination significantly improved survival for patients with metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, reducing the risk of death by 20%. Additionally, 55% of patients were still alive at one year,” said Yelena Y. Janjigian, M.D., CheckMate -649 principal investigator and chief of gastrointestinal oncology, Memorial Sloan Kettering Cancer Center. “These findings are important, reinforcing the potential of this Opdivo-based combination as a standard of care for this population of patients in high need of treatment options that may extend their lives.”

 “We are focused on bringing transformative medicines to patients in need, and historically, there has been little progress for patients diagnosed with these metastatic gastroesophageal adenocarcinomas,” said Adam Lenkowsky, general manager and head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb. “As demonstrated in the CheckMate -649 trial, Opdivo is the first and only immunotherapy combined with chemotherapy to deliver superior overall survival versus chemotherapy alone in first-line metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Today’s approval may offer these patients hope for the chance at a longer life.”