FDA Modifies Nivolumab Dosage Regimens for RCC, NSCLC, Melanoma

The U.S. Food and Drug Administration (FDA) has modified the dosage regimen for nivolumab for the approved indications for unresectable or metastatic melanoma, metastatic non-small cell lung cancer (NSCLC), and advanced renal cell carcinoma (RCC).¹

The single-agent nivolumab regimens were changed from 3 mg/kg intravenously every 2 weeks to the new recommended flat-dose regimen of 240 mg intravenously every 2 weeks until disease progression or unacceptable toxicity.

The regimen of nivolumab in combination with ipilimumab for the treatment of unresectable or metastatic melanoma will continue to be nivolumab 1 mg/kg intravenously, followed by ipilimumab on the same day, every 3 weeks for 4 doses. Following the completion of 4 doses of ipilimumab, nivolumab will be continued at a dose of 240 mg (instead of 3 mg/kg) every 2 weeks until disease progression or unacceptable toxicity.

The recommended dose and schedule of nivolumab for the treatment of classical Hodgkin lymphoma remains 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity.

These modifications to the prescribing information are based on findings from population pharmacokinetic analyses and dose/exposure-response analyses, which showed that the overall exposure at 240 mg every 2 weeks is similar to the exposure at 3 mg/kg every 2 weeks.

The differences in exposure between the 3 mg/kg dose and the 240 mg flat-dose are not expected to have a clinically meaningful impact on efficacy or safety.                         

Reference

1. Modification of the dosage regimen for nivolumab. U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm520871.htm. Updated September 15, 2016. Accessed September 16, 2016.