European Commission Approves 4-Week Nivolumab Dosing Schedule in Adjuvant Melanoma
Source: OncLive, November 2019
The European Commission has approved nivolumab (Opdivo) 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.1
“The approval of Opdivo two- and four-week flat dosing schedule in the adjuvant melanoma setting is an important milestone for patients across the European Union who now have additional treatment flexibility,” Ralu Vlad, PharmD, development team lead, product design and delivery, Bristol-Myers Squibb, the developer of the PD-1 inhibitor, stated in a press release. “Bristol Myers-Squibb is committed to empowering patients with cancer and their families to regain control of their lives through more flexible treatment options that fit their individual needs.”
The approval follows a positive opinion granted in September 2019 by the European Medicines Agency’s Committee for Medicinal Products for Human Use.