FDA Approves Opdivo to Treat Advanced Esophageal Squamous Cell Carcinoma

The Food and Drug Administration (FDA) approved Opdivo (nivolumab) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy, according to Bristol Meyers Squibb — the agent’s manufacturer.

“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,” Adam Lenkowsky, general manager and head of US oncology, immunology and cardiovascular at Bristol Myers Squibb, said in a press release.

“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,” he added.

The agency based the priority review and approval on results from the multicenter, randomized, active-controlled, open-label global phase 3 ATTRACTION-3 trial — designed to evaluate Opdivo (210 patients), compared with taxane chemotherapy (docetaxel or paclitaxel; 209 patients). The trial included patients regardless of tumor PD-L1 status.

In the trial, patients treated with Opdivo demonstrated superior median overall survival, compared with chemotherapy (10.9 months versus 8.4 months).

Check back later for what you need to know about this approval.