Opdivo Receives FDA Approval in Melanoma Treatment

Today, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) for the adjuvant treatment of patients with melanoma that has involvement of lymph nodes or metastatic disease, and who have undergone complete resection. Nivolumab is the first and only anti-programmed death (PD)-1 immune checkpoint inhibitor that is approved for adjuvant treatment of melanoma, and is indicated for both BRAF mutant and wild type patients.

In the phase 3 CheckMate-238 trial, nivolumab significantly improved recurrence-free survival (RFS) versus ipilimumab (Yervoy, Bristol-Myers Squibb), in patients with stage III/C or stage IV melanoma after surgery. This result was observed across multiple subgroups, including both BRAF mutant and BRAF wild-type patients.

“Today’s approval builds on our leadership in melanoma, offering physicians a new option with the potential to change the course of the disease through earlier intervention. Opdivo is the first PD-1 inhibitor approved as an adjuvant treatment for any cancer,” said Johanna Mercier, head, US commercial, Bristol-Myers Squibb. “Our decision to study Opdivo versus Yervoy—an established standard of care with a proven survival benefit—represents our relentless pursuit to bring more effective treatments to patients.”

Opdivo demonstrated an 18-month RFS rate of 66.4% (95% CI: 61.8 to 70.6) compared with 52.7% for Yervoy (95% CI: 47.8 to 57.4), with the median RFS not yet determined in either group. Opdivo reduced the risk of disease recurrence by 35% versus Yervoy (hazard ratio [HR]: 0.65; 95% CI: 0.53 to 0.80; p <0.0001).

In September 2017, nivolumab received “Breakthrough Therapy Designation” from the FDA for the adjuvant treatment of patients with high-risk, fully resected melanoma.