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# Janssen’s Darzalex Faspro OK’d for Multiple Myeloma
- URL: https://www.fdaweb.com/janssens-darzalex-faspro-okd-for-multiple-myeloma/
- Published: 2021-07-12T12:00:00.000Z
- Updated: 2026-09-14T17:05:52.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149683

FDA has approved a Janssen Biotech BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. Approval was based on data from the 304-patient APOLLO trial, which showed median progression-free survival of 12.4 months in the Darzalex Faspro treatment group and 6.9 months in the pomalidomide and dexamethasone treatment group, an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-pomalidomide-and-dexamethasone-multiple-myeloma?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. The most common adverse reactions were fatigue, pneumonia, upper respiratory tract infection, and diarrhea.