FDA Modifies Dosing Regimen for Nivolumab

The new dosage regimen is for 240mg IV every 2 weeks
The new dosage regimen is for 240mg IV every 2 weeks

The Food and Drug Administration (FDA) has approved a modification to the nivolumab (OpdivoBristol-Myers Squibb) dosage regimen for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer. 

The new dosage regimen is for 240mg IV every 2 weeks until disease progression or intolerable toxicity for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer. This replaces the single-dose nivolumab 3mg/kg given intravenously (IV) every 2 weeks regimen.

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The nivolumab dosing regimen in combination with ipilimumab for melanoma treatment will stay the same with nivolumab 1mg/kg IV, followed byipilimumab on the same day, every 3 weeks for 4 doses. After completing ipilimumab, however, the recommended nivolumab dose will be 240mg every 2 weeks until disease progression or intolerable toxicity. 

The recommended dose for classical Hodgkin lymphoma will stay as 3mg/kg IV every 2 weeks until disease progression or intolerable toxicity. 

The FDA approval was supported by population pharmacokinetic analyses and dose/exposure-response analyses demonstrating the comparability between the previously approved and the proposed new dosing regimen in terms of pharmacokinetics exposure, safety, and efficacy. The FDA concluded that overall exposure of 240mg every 2 weeks as a flat dose was similar (<6% difference) to 3mg/kg every 2 weeks. It was determined that these differences in exposure were not likely to have a clinically meaningful impact on safety and efficacy. 

Opdivo, a human programmed death receptor-1 (PD-1)-blocking antibody, is available as 40mg/4mL and 100mg/10mL strength solutions in single-dose vials.

For more information call (800) 721-5072 or visit Opdivo.com.

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