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FDA changes dosing regimen for Opdivo in three approved indications
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The FDA modified the dosing regimen for nivolumab in its currently approved indications for renal cell carcinoma, metastatic melanoma and non–small cell lung cancer.
The nivolumab (Opdivo, Bristol-Myers Squibb) dosing regimen has changed from 3 mg/kg to 240 mg intravenously every 2 weeks until disease progression or intolerable toxicity.
For the treatment of melanoma, the dosing regimen of 1 mg/kg of IV nivolumab in combination with ipilimumab (Yervoy, Bristol-Meyers Squibb) will remain the same. However, after therapy with ipilimumab is complete, the regimen will change to a 240-mg dose every 2 weeks until disease progression or intolerable toxicity.
The recommended dose of 3 mg/kg intravenously every 2 weeks until disease progression or intolerable toxicity for the treatment of classical Hodgkin lymphoma also will remain the same.
The FDA based its approval on population pharmacokinetics analyses and dose/exposure-response analyses, in which the overall exposure of a flat dose at 240 mg every 2 weeks appeared similar to the previous dosing regimen.
The FDA found these differences in exposure unlikely to have a “clinically meaningful” effect on safety and efficacy because the dose/exposure-response relationships appeared to be relatively flat in all three indications.