Categorized | Melanoma News, Regulatory

Once Monthly Opdivo Use Approved in EU for Certain Melanoma, Renal Cell Cancer Patients

Source: Immuno-Oncology News, May 2018

The European Commission has approved a new dosing schedule for Opdivo(nivolumab), allowing the PD-1 inhibitor to be given every four weeks to patients with advanced melanoma and those with previously treated renal cell carcinoma.
The approval means that physicians may now choose to prescribe the medicine either as a 480 mg, 60-minute infusion every four weeks, or as a 240 mg infusion given over 30 minutes every two weeks. This two-week dose is an option replacing weight-based dosing for all six of its approved uses across the European Union.
Opdivo is the first and only PD-1 inhibitor approved in the EU to offer every four-week dosing as a treatment option.
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