> ## 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.

# FDA Approves Darzalex Faspro for Myeloma
- URL: https://www.fdaweb.com/fda-approves-darzalex-faspro-for-myeloma/
- Published: 2021-12-01T12:00:00.000Z
- Updated: 2026-09-14T17:24:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150677

FDA has approved Janssen’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with Kyprolis (carfilzomib) and dexamethasone (Kd) to treat adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. The company [says](https://prnmedia.prnewswire.com/news-releases/us-fda-approves-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-in-combination-with-carfilzomib-and-dexamethasone-for-patients-with-multiple-myeloma-after-first-or-subsequent-relapse-301435448.html?ref=fdaweb.com) the safety profile of Darzalex Faspro plus carfilzomib and dexamethasone was consistent with the known safety profiles of the component drugs. The most common adverse reactions were upper respiratory tract infection, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and peripheral edema. Fatal adverse reactions occurred in 3% of patients.