The Committee for Medicinal Products for Human Use of the European Medicines Agency as recommended approval of Opdivo (nivolumab) for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy.
Opdivo is sponsored by Bristol Myers Squibb.
The European Commission, which has the authority to approve medicines for the European Union, will now review the CHMP recommendation.
The positive opinion is based on results from the phase III CheckMate -577 trial, which showed that treatment with Opdivo following neoadjuvant CRT and complete surgical resection doubled the primary endpoint of disease-free survival compared to placebo in the all-randomized population. The safety profile of Opdivo was consistent with previously reported studies. Results from CheckMate -577 were presented at the 2020 European Society for Medical Oncology virtual congress in September 2020 and at the American Society of Clinical Oncology annual meeting in June 2021.
Opdivo is approved in the United States for the adjuvant treatment of completely resected esophageal or GEJ cancer with residual pathologic disease in patients who have received neoadjuvant CRT.
