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All Oncology News

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of nivolumab at a flat dosing schedule of either 240 mg over 30 minutes every 2 weeks, or 480 mg infused over 60 minutes every 4 weeks, for the adjuvant treatment of patients with melanoma who have involvement of lymph nodes or metastatic disease who have undergone complete resection.

The uptick of biosimilars has led to a surge of new data and regulatory decisions in recent years, with a focus on similarity between biosimilars and their reference products while reducing healthcare costs. This week, data on subcutaneous formulations of one biosimilar and long-term experience with another were provided, as well as an authorization of a trastuzumab (Herceptin) biosimilar in Canada.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion to recommend approval of the combination of avelumab and axitinib for the frontline treatment of adult patients with advanced renal cell carcinoma.