Bristol Myers Squibb gets European Commission nod for Opdivo as adjuvant treatment for patients with completely Resected Stage IIB or IIC Melanoma

This approval builds upon the 2018 EC approval based on results from the CheckMate -238 trial. Opdivo is now indicated for use in the European Union as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Opdivo is now the only PD-1 inhibitor that – between two approvals – is indicated as an adjuvant treatment within stages IIB, IIC, III, as well as stageIV resected melanoma.

“Patients with stage IIB or IIC melanoma are at a high risk of disease recurrence following surgery. This can be a very impactful event for patients,” said Peter Mohr, MD, Chief Physician and Head, Skin Cancer Center, Buxtehude, Department of Dermatology, Elbe-Kliniken, Germany. “This approval reinforces the benefit that nivolumab may offer when used after resection, potentially preventing the disease from recurring.”

The EC’s decision is based on results from the Phase 3 CheckMate -76K trial, in which, with a minimum follow-up of 7.8 months, Opdivo reduced the risk of recurrence or death in patients with stage IIB or IIC melanoma by 58% versus placebo (hazard ratio [HR] 0.42; 95% CI: 0.30-0.59; p<0.0001). The safety profile of Opdivo was consistent with previously reported studies.

CheckMate -76K is part of Bristol Myers Squibb’s development program which explores the use of Opdivo and Opdivo-based combinations in earlier stages of cancer.

“With this approval, we can now offer patients in the European Union with stage IIB or IIC resected melanoma an efficacious treatment option that significantly reduced the risk of disease recurrence,” said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb. “This approval builds on our long-standing commitment to bring innovative medicines to patients across the cancer spectrum, including in earlier stages of cancer. We thank all the patients, researchers, and physicians who were involved along the way to help make this additional option for patients possible.”

The EC approval covers all European Union member states, as well as Iceland, Liechtenstein, and Norway. Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland, Wales).