FDA Approves BMS’ Opdivo for Advanced ESCC After Chemotherapy

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #bms #escc #esophagealcancer #fda #priorityreview


PRICENTRIC BRIEF:
  • The U.S. Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab) for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), following prior fluoropyrimidine- and platinum-based chemotherapy
  • Approval from the U.S. regulator is based on results from the Phase 3 ATTRACTION-3 trial in which Opdivo demonstrated superior overall survival (OS) compared to taxane chemotherapy; the median OS for Opdivo was 10.9 months versus 8.4 months for docetaxel or paclitaxel
  • Opdivo is the first immunotherapy greenlighted in this setting, regardless of the amount of tumor PD-L1 expression

 

THE DETAILS

WASHINGTON, D.C., The United States – The U.S. Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab) for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), following prior fluoropyrimidine- and platinum-based chemotherapy.

The FDA granted the application Priority Review Designation. With this approval, Opdivo is the first immunotherapy greenlighted in this setting, regardless of the amount of tumor PD-L1 expression.

Approval from the U.S. regulator is based on results from the Phase 3 ATTRACTION-3 trial in which Opdivo demonstrated superior overall survival (OS) compared to taxane chemotherapy; the median OS for Opdivo was 10.9 months versus 8.4 months for docetaxel or paclitaxel.

Adam Lenkowsky, General Manager and Head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb, said, “Many cases of esophageal cancer are diagnosed at the advanced stage, when the disease could have a significant impact on a patient’s health. Treatment options can be limited once patients with advanced esophageal squamous cell carcinoma progress.

“The approval of Opdivo as a new treatment option for previously treated patients with advanced esophageal squamous cell carcinoma, regardless of PD-L1 expression, highlights our commitment to providing new options to address the unmet needs of patients and brings us another step closer to understanding the full potential of immunotherapy for gastrointestinal cancers.”

 

Learn more about Pricentric ONE and our Global Pricing Solutions!

Contact us with your questions and global pricing needs, and an expert will follow up shortly.