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# Janssen sBLA for Darzalex Combination Use for Myeloma
- URL: https://www.fdaweb.com/janssen-sbla-for-darzalex-combination-use-for-myeloma/
- Published: 2020-02-10T12:00:00.000Z
- Updated: 2026-09-14T16:02:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146055

FDA has accepted for review a Janssen Pharmaceutical supplemental BLA for Darzalex (daratumumab) for use in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone for relapsed/refractory multiple myeloma. The submission is supported by data from the Phase 3 CANDOR study, which compared treatment with the triple therapy to carfilzomib and dexamethasone in patients with multiple myeloma who relapsed after one to three prior lines of therapy.

CANDOR evaluated 466 relapsed or refractory patients with multiple myeloma who had received one to three prior lines of therapy from 120 global sites. Patients were treated until disease progression, and the primary endpoint was progression free survival, according to the company. Key secondary endpoints were overall response rate, minimal residual disease and overall survival. CANDOR is an Amgen-sponsored study and is co-funded by Janssen.

In the U.S., Darzalex was approved as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent. In 2016, it was approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treating patients with multiple myeloma who have received at least one prior therapy. In 2017, it was approved in combination with pomalidomide and dexamethasone for treating patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a PI.