> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Amgen sNDA on Kyprolis Superiority Data Under FDA Review
- URL: https://www.fdaweb.com/amgen-snda-on-kyprolis-superiority-data-under-fda-review/
- Published: 2017-08-30T12:00:00.000Z
- Updated: 2026-09-14T22:45:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139513

FDA has accepted an Amgen supplemental NDA for Kyprolis (carfilzomib) and dexamethasone that includes overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial demonstrating that the therapies reduced the risk of death by 21% and increased OS by 7.6 months versus Velcade (bortezomib) and dexamethasone in patients with relapsed or refractory multiple myeloma. The agency has set a user fee review target action date of 4/30/2018\. If approved, the sNDA will amend Kyprolis’ U.S. prescribing information to include this data from the ENDEAVOR trial showing that the therapy, administered at the 56 mg dose as a 30-minute infusion twice weekly with dexamethasone, helped relapsed or refractory multiple myeloma patients live longer than patients administered Velcade, according to the company.