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
Regulatory
Ipilimumab Approved in Europe for Pediatric Melanoma
Ipilimumab (Yervoy) has been approved by the European Commission for the treatment of patients aged 12 and older with unresectable or metastatic melanoma.
Nivolumab Earns FDA Approval as Adjuvant Therapy for Melanoma Based on Checkmate-238 Trial
According to the National Cancer Institute, about 2.2% of people will be diagnosed with melanoma at a point in their lifetime.
Ipilimumab Approaches EU Approval for Pediatric Melanoma
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of ipilimumab (Yervoy) for the treatment of pediatric patients aged 12 years and older with unresectable or metastatic melanoma, according to Bristol-Myers Squibb (BMS), the manufacturer of the CTLA-4 inhibitor.