Janssen Gets U.S. FDA Approval of DARZALEX FASPRO Combo for Multiple Myeloma

 Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. The approval marks Janssen's sixth indication for DARZALEX FASPRO® in the treatment of multiple myeloma. Findings from the Phase 3 APOLLO study were recently published in The Lancet Oncology.

DARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.

https://www.wfmz.com/news/pr_newswire/pr_newswire_health/halozyme-announces-janssen-receives-u-s-fda-approval-of-darzalex-faspro-daratumumab-and-hyaluronidase-fihj/article_68029aa2-72b1-5d44-911e-80969c6481c4.html