October 16, 2020 -- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Bristol Myers Squibb's nivolumab (Opdivo).
Opdivo is a programmed cell death 1 (PD-1) immune checkpoint inhibitor designed to use the body's own immune system to help restore antitumor immune responses. In this instance, Bristol Myers Squibb is using the drug for the treatment of adults with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.
In terms of next steps, now the European Commission (EC) will decide whether to approve the medicine. If approved, Opdivo will be the first immunotherapy approval for any upper gastrointestinal cancer in the European Union (EU), Bristol Myers Squibb said.
CHMP's recommendation is based on results from the phase III multicenter, randomized Attraction-3 trial, which demonstrated a statistically significant improvement in overall survival in patients who received Opdivo versus chemotherapy. Patients were refractory or intolerant to at least one fluoropyrimidine- and platinum-based combination regimen, regardless of programmed cell death ligand 1 (PD-L1) expression level, Bristol Myers Squibb said.
Thus far, Opdivo has been approved in five countries, including the U.S., for the second-line treatment of patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma, the firm added.