FDA Accepts sNDA for Carfilzomib Label Update in Myeloma

August 31, 2017 – The FDA has accepted a supplemental new drug application (sNDA) seeking to add overall survival (OS) data from the phase III ENDEAVOR trial to the label for carfilzomib for use in patients with relapsed or refractory multiple myeloma. Results from the primary ENDEAVOR OS analysis recently published in the Lancet Oncology showed that carfilzomib reduced the risk of death by 21% compared with bortezomib in patients with relapsed/ … (leggi tutto)