Amgen and its subsidiary Onyx Pharmaceuticals, Inc, announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) carfilzomib (Kyprolis) to seek approval for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The sNDA is designed to support the conversion of accelerated approval to full approval and expand the current approved indication.
Carfilzomib, a proteasome inhibitor, was granted accelerated approval by the FDA in 2012.
The submission is based on data from the phase III ASPIRE trial of carfilzomib, lenalidomide (Revlimid), and dexamethasone vs lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma, and other relevant data.
“Multiple myeloma is an incurable blood cancer that often becomes resistant to treatment, underscoring the need for new therapeutic options that provide deep and durable responses to extend the time patients live without their disease progressing,” said Pablo J. Cagnoni, MD, President of Onyx Pharmaceuticals. ■