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Amgen Files sNDAs for Carfilzomib to Treat Multiple Myeloma in Europe, US

Jason Harris
Published: Friday, Jul 14, 2017

Sean E. Harper, MD

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.

References

  1. Stewart KA, Rajkumar VS, Dimopoulos MA, et al. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015; 372:142-152.
  2. 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.

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