FDA Approves Immune-Oncology Combination for Melanoma
the ONA take:
The US Food and Drug Administration (FDA) has granted accelerated approval to a regimen consisting of nivolumab and ipilimumab for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
Nivolumab should be administered at a dose of 1 mg/kg intravenously over 60 minutes, followed by ipilimumab 3 mg/kg intravenously on the same day, every 3 weeks for four doses, then nivolumab 3 mg/kg over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
In regard to safety, the most common adverse reactions in patients receiving the combination in clinical trials were rash, pruritus, headache, vomiting, and colitis.
The most frequent grade 3 or 4 laboratory abnormalities were increased ALT, increased AST, increased lipase, increased amylase, hyponatremia, and lymphopenia.
Health care professionals should monitor for changes in liver function, renal function, and thyroid function.
The regimen was evaluated in 142 patients with unresectable or metastatic melanoma. Participants were randomly assigned to receive nivolumab plus ipilimumab or ipilimumab alone.
Results showed that the combination stopped cancer progression in 60% of patients with BRAF V600 wild-type disease compared with 11% in the ipilimumab alone arm.
Both drugs are also approved as monotherapy for the treatment of unresectable or metastatic melanoma.
Accelerated approval for nivolumab and ipilimumab for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
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