Bristol Myers Squibb (BMS) has announced that its heavy PD-1 inhibitor Opdivo (nivolumab) has been approved by the U.S. FDA to treat patients with advanced, recurrent or metastatic esophagus squamous cell cancer (ESCC) who are not removable after chemotherapy with fluoroureandi and platinum drugs, regardless of tumor PD-L1 expression levels.
esophageal cancer is a type of digestive tract tumor that starts in the esophagus and grows continuously.
cancer caused by the normal lining of the mucous membrane squamous cell carcinoma is called squamous cell carcinoma.
for about 25 percent of patients, the disease is diagnosed at a late stage, when the patient's treatment options are very limited.
approval is based on the results of Phase 3 clinical trial ATTRACTION-3, in which Opdivo (n-210) showed better overall survival (OS) than sequoia chemotherapy (n-209) (HR-0.77; 95% CI:0.62 to 0.96; p-0.0189).
the median OS in the Opdivo group was 10.9 months (95% CI: 9.2-13.3), and the Dosita or Yewol group was 8.4 months (95% CI: 7.2-9.9).
"Many cases of esophageal cancer are diagnosed at a later stage and have a significant impact on the patient's health."
treatment options are limited as soon as patients with advanced esophageal squamous cell carcinoma progress," said Dr. Adam Lenkowsky, head of cardiovascular oncology immunology at Persimmon, "Opdivo is approved as a new therapeutic option for patients with advanced advanced esophageal squamous cell carcinoma, regardless of their PD-L1 expression, highlighting our commitment to providing new options to address unmet patient needs and taking us closer to understanding the full potential of gastrointestinal treatment."
" original title: Express , regardless of PD-L1 expression, 100-day-mecone Squibb PD-1 inhibitor searly was approved for the treatment of advanced esophageal squamous cell carcinoma.