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.

RELATED: Cabazitaxel Active in Docetaxel-resistant Non-small Cell Lung Cancer

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.