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FDA Adds Survival Data to Carfilzomib Myeloma Label

Jason M. Broderick @jasoncology
Published: Tuesday, Jun 12, 2018

David M. Reese, MD

David M. Reese, MD

The FDA approved a supplemental new drug application (sNDA) adding overall survival (OS) data from the phase III ASPIRE trial to the label for carfilzomib (Kyprolis) for use in patients with relapsed or refractory multiple myeloma, according to Amgen, the manufacturer of the proteasome inhibitor. 

Carfilzomib is currently approved in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received 1 to 3 lines of therapy. The treatment is also approved as a monotherapy for relapsed/refractory myeloma patients who have received 1 or more lines of therapy.

References

  1. FDA Approves Addition Of Positive Overall Survival Data From Phase 3 ASPIRE Trial To KYPROLIS® (carfilzomib) Label. Amgen. https://bit.ly/2LFIJbA. Published June 11, 2018. Accessed June 12, 2018.
  2. Stewart KA, Rajkumar VS, Dimopoulos MA, et al. Carfilzomib, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma. N Engl J Med. 2015; 372:142-152.
  3. Dimopoulos MA, Goldschmidt H, Niesvizky R, et al. Carfilzomib or bortezomib in relapsed or refractory multiple myeloma (ENDEAVOR): an interim overall survival analysis of an open-label, randomised, phase 3 trial [published online August 23, 2017]. Lancet Oncol. doi: 10.1016/ S1470-2045(17)30578-8.

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