FDA Approves Melanoma Treatment

fda alertThe FDA has approved a treatment for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.


Nivolumab (Opdivo, Bristol-Myers Squibb) was granted approval in the adjuvant setting for patients with completely resected melanoma with lymph node involvement or metastatic disease. The approval came following findings from a phase 3 trial (CheckMate-238), which showed a 35% risk reduction in recurrence or death with nivolumab compared with a different inhibitor (ipilimumab, Yervoy). In the CheckMate-238 trial, treatment demonstrated an 18-month recurrence-free survival (RFS) rate of 66.4% [95% confidence interval (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 reached in either group. Nivolumab reduced the risk of disease recurrence by 35% versus ipilimumab [hazard ratio (HR): 0.65; 95% CI: 0.53 to 0.80; P<0.0001].

The most frequent adverse reactions reported were diarrhea and increased lipase, amylase, fatigue, diarrhea, rash, musculoskeletal pain, pruritus, headache, nausea, upper respiratory infection and abdominal pain. Additional adverse reactions reported, included immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions; infusion reactions; and embryo-fetal toxicity.

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

Julie Gould


Bristol-Myers Squibb. Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease [press release]. https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-receives-fda-approval-opdivo-nivolumab-ad. Published December 20, 2017. Accessed December 21, 2017.