FDA Approves Opdivo for Advanced Esophageal Squamous Cell Carcinoma Regardless of PD-L1 Status

On June 10, BMS announced that the FDA had approved a new indication for Opdivo for the treatment of patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) who had previously received fluoropyrimidine- and platinum-based therapy. This is the first immunotherapy approved for this patient population, regardless of PD-L1 status.

This approval is based on the results of the Phase III ATTRACTION-3 study, which demonstrated that the Opdivo treatment group (n=210) achieved prolonged survival compared to the taxane chemotherapy group (n=209) (HR 0.77; 95% CI: 0.62-0.96; p=0.0189). The median OS was 10.9 months in the Opdivo group and 8.4 months in the taxane chemotherapy group.

Source: NextPharma

It is estimated that in the United States in 2020, there will be 18,440 new cases of diagnosed esophageal cancer and approximately 16,170 deaths. Of these, less than 30% are cases of esophageal squamous cell carcinoma. Approximately 25% of patients are diagnosed at an advanced stage, which is often difficult to treat.