FDA Amends Opdivo Dosage in Three Indications
FDA modified the dosage regimen for Opdivo — setting 240 mg intravenously every two weeks, until disease progression or intolerable toxicity — in approved indications for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer.
The approval replaced the previous single dose regimen of Bristol-Myers Squibb’s immunotherapy, of 3 mg/kg intravenously every two weeks.
The combination regimen for Opdivo (nivolumab) and Yervoy (ipilimumab) in melanoma will remain the same, at Opdivo 1 mg/kg IV, followed by Yervoy on the same day, every three weeks for four doses. However, after completion of Yervoy, the recommended Opdivo dose will be 240 mg every two weeks. The recommended dose for classical Hodgkin lymphoma will remain at 3 mg/kg IV every two weeks.