Amgen, Inc. (NASDAQ:AMGN) reported that the CHMP of the European Medicines Agency has adopted a positive stance to expand the existing indication for XGEVA® to cover skeletal-linked events in people with multiple myeloma. If permitted, XGEVA will be meant for the prevention of skeletal-linked events in people with advanced malignancies involving bone.
Amgen reported that the application comprised new data from the Phase III ‘482 trial, the largest global multiple myeloma study for the prevention of skeletal-linked events ever performed. In the ‘482 trial, XGEVA met the primary endpoint, showcasing non-inferiority to zoledronic acid in deferring the time to first on-trial skeletal-related event in people with multiple myeloma. The median time to first on-trial skeletal-linked event came at 22.83 months for XGEVA while it was 23.98 months for zoledronic acid.
David M. Reese, M.D., the SVP of Translational Sciences and Oncology, expressed that over 90% of people with multiple myeloma advance bone lesions over the progression of the disease. These can lead in fractures and other bone problems. The positive stance from the CHMP to extend XGEVA’s indication to include skeletal-related events in people with multiple myeloma is a vital step forward in company’s commitment to enhancing care for people with multiple myeloma at risk for getting bone complications.
Bone complications, also termed as skeletal-related events, are stated as radiation to bone, surgery to bone, spinal cord compression and pathologic fracture. Following the CHMP positive stance, the centralized EMA of XGEVA will be expanded to include the multiple myeloma patient population. Iceland, Liechtenstein and Norway, as members of the EEA, will take corresponding judgments on the basis of the verdict of the European Commission. XGEVA marks as the initial fully human monoclonal antibody meant for binding and neutralizing RANK ligand, a protein required for the formation, survival and function of osteoclasts.