Jan. 4, 2018—Bristol-Myers Squibb announced the FDA has approved Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. The purpose of adjuvant therapy is to reduce the risk of recurrence following surgical removal of the tumor and lymph nodes that contain cancer. In the phase three CHECKMATE-238 trial, Opdivo significantly improved recurrence-free survival versus an active comparator, Yervoy (ipilimumab), in patients with stage IIIB/C or stage IV melanoma after surgery. This benefit was observed across important subgroups, including in BRAF mutant and BRAF wild-type patients. Opdivo is the first agent approved for the adjuvant treatment of melanoma based on a head-to-head trial against an active comparator with a proven overall survival benefit.
“Immuno-oncology has transformed the treatment of metastatic melanoma and many other cancers over the last decade, and we are now extending the use of novel agents to help prevent the recurrence of melanoma,” Jeffrey S. Weber, MD, PhD, deputy director, Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, and professor of medicine at NYU School of Medicine, said in a release from BMS. “When melanoma has been removed surgically, physicians and patients alike sometimes struggle with the idea of further adjuvant treatment because the disease is no longer detectable, even though it may be likely to return. We recognized a need to develop new adjuvant treatments with lower toxicity compared to ipilimumab to help address this challenge. With its impressive efficacy and broad applicability within stage III and IV melanoma, nivolumab has the potential to become the next standard of care in preventing recurrence of melanoma following surgical resection.”