The EC approval is based on Phase 3 ATTRACTION-3 trial, which showed positive results for Opdivo in improving overall survival compared to chemotherapy
EC approves Bristol Myers’ Opdivo for ESS treatment. (Credit: Sébastien Bertrand/Wikimedia.org.)
Bristol Myers Squibb has secured the European Commission (EC) approval for Opdivo (nivolumab) to treat a type of oesophageal squamous cell carcinoma (ESCC) in adults.
The EC approval indicated Opdivo as a second-line treatment for unresectable advanced, recurrent or metastatic ESCC, after treatment using fluoropyrimidine- and platinum-based chemotherapy combination.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, designed to strengthen the body’s immune system to fight cancer, by helping the body restore its anti-tumour immune response.
Bristol Myers Squibb gastrointestinal cancers development lead Ian M Waxman said: “Today’s approval marks a critically important milestone for those living with esophageal squamous cell carcinoma, as this is the first time an immunotherapy treatment option has been approved in the European Union for this patient population.
“We are proud of our work in advancing treatment options for people living with upper gastrointestinal cancers, and we look forward to working with European stakeholders to bring Opdivo to more eligible patients who may benefit.”
The European regulator has approved the drug based on results from the Phase 3 ATTRACTION-3 trial, which is conducted by Japan-based Ono Pharmaceutical.
ATTRACTION-3 is a Phase 3 multi-centre, randomised, open-label clinical trial that evaluated Opdivo, compared to chemotherapy including docetaxel or paclitaxel, in esophageal cancer patients, intolerant to fluoropyrimidine- and platinum-based drugs.
In the Phase 3 trial, treatment using Opdivo showed statistically significant and clinically meaningful improvement in overall survival (OS), which is the primary endpoint of the study, compared to chemotherapy.
Opdivo reduced risk of death by 23%, compared to chemotherapy alone, and showed a favourable safety profile compared with chemotherapy and was consistent with previously conducted studies of the drug, in treating other solid tumours.
In addition to the EU approval, the drug has been approved in the US and Japan for the same indication, as second-line treatment of unresectable, advanced, metastatic ESCC.
In addition to the current EU approval, the drug has been approved in the US and Japan for the same indication, as second-line treatment of unresectable, advanced, metastatic ESCC.