Categorized | Melanoma News, Regulatory

Europe Approves New Nivolumab Dosing Schedules

Source: Targeted Oncology, May 2018

A 4-week dosing schedule for nivolumab (Opdivo) has been approved by the European Commission for the treatment of patients with advanced melanoma and previously treated renal cell carcinoma (RCC), Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor, has announced.
The commission specifically approved a 4-week dosing regimen with 480 mg of nivolumab for these indications. Additionally, the commission approved replacing weight-based dosing with 240 mg every 2 weeks for the 6 nivolumab monotherapy indications approved in the European Union—melanoma, non–small cell lung cancer (NSCLC), RCC, classical Hodgkin lymphoma, head and neck squamous cell carcinoma (HNSCC), and urothelial carcinoma.
“This approval marks a significant achievement in our longstanding commitment to providing patients and healthcare providers with more flexible and convenient treatment options,” Fouad Namouni, MD, head of development, Oncology, BMS, said in a statement. “Bristol Myers-Squibb is dedicated to addressing the unique needs of patients, and with this approval, we will now be able to offer a range of dosing options for an immuno-oncology medicine approved in the European Union.”
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