Sean E. Harper, MD
Amgen has announced that it has submitted supplemental New Drug Applications (sNDA) in the United States and Europe based on data from 2 phase III studies showing carfilzomib (Kyprolis) improves overall survival (OS) for patients with relapsed/refractory multiple myeloma.
The FDA expanded the approval for carfilzomib in July 2015 to include patients with relapsed multiple myeloma who received at least 1 to 3 prior lines of therapy, based on results from the phase III ASPIRE trial. Carfilzomib had previously received an accelerated approval in July 2012 as a treatment for patients with multiple myeloma following at least 2 therapies, including bortezomib and an immunomodulatory agent.
- Stewart KA, Rajkumar VS, Dimopoulos MA, et al. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015; 372:142-152.
- Dimopoulos MA, Moreau P, Palumbo A, et al. Carfilzomib and dexamethasone (Kd) vs bortezomib and dexamethasone (Vd) in patients (pts) with relapsed multiple myeloma (RMM): results from the phase III study ENDEAVOR. J Clin Oncol. 2015;(suppl; abstr 8509). http://ascopubs.org/doi/abs/10.1200/jco.2015.33.15_suppl.8509.
... to read the full story