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.

read the original full article

Melanoma Google Alerts

Melanoma Google Alerts is a summary of daily articles found in print and on the internet. The articles do not necessarily represent the views of Melbourne Melanoma Project

News Archives

News Categories