Categorized | Melanoma News, Regulatory

European Panel Backs New Nivolumab Dosing Schedules

Source: OncLive, April 2018

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended adding the option of a 4-week dosing schedule to the label for nivolumab (Opdivo) for the treatment of patients with advanced melanoma and previously treated renal cell carcinoma (RCC).1
The committee is recommending approval of a 4-week dosing regimen with 480 mg of nivolumab for these indications. The panel has also issued its support for replacing weight-based dosing with 240 mg every 2 weeks for the 6 nivolumab monotherapy indications approved in the European Union (EU)—melanoma, non–small cell lung cancer (NSCLC), RCC, classical Hodgkin lymphoma, head and neck squamous cell carcinoma (HNSCC), and urothelial carcinoma.
Bristol-Myers Squibb’s (BMS’s) Marketing Authorization Application will now go to the full European Commission. If approved, these dosing options will be available throughout the EU.
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