Amgen submitted a supplemental New Drug Application to the FDA for Kyprolis (carfilzomib) for Injection to seek an expanded indication for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The sNDA is based on data from the global ENDEAVOR trial. ENDEAVOR is the first of two head-to-head...
In a unanimous vote, the FDA Oncologic Drugs Advisory Committee advised the agency to accept the metric of “minimal residual disease,” or MRD, as a basis for accelerated approvals of therapies in all settings of multiple myeloma.Â
