European Commission Green Lights Opdivo as an Adjuvant Treatment for Completely Resected Stage IIB or IIC Melanoma

Opdivo is the only PD-1 inhibitor that is indicated as an adjuvant treatment for patients within stages IIB, IIC, III, as well as stage IV resected melanoma.

The European Commission (EC) has approved Opdivo (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection, Bristol Myers Squibb reports.

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).

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. It is the only PD-1 inhibitor that – between two approvals – is indicated as an adjuvant treatment within stages IIB, IIC, III, as well as stage IV 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,” says Peter Mohr, MD, Chief Physician and Head, Skin Cancer Center, Buxtehude, Department of Dermatology, Elbe-Kliniken, Germany, in a news release. “This approval reinforces the benefit that nivolumab may offer when used after resection, potentially preventing the disease from recurring.”

In the Phase 3 CheckMate -76K trial, Opdivo reduced the risk of recurrence or death in patients with stage IIB or IIC melanoma by 58% versus placebo in a minimum follow-up of 7.8 months. 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,” adds 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.”