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Darzalex Faspro FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 25, 2021.

FDA Approved: Yes (First approved May 1, 2020)
Brand name: Darzalex Faspro
Generic name: daratumumab and hyaluronidase-fihj
Dosage form: Injection
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Multiple Myeloma; Light Chain (AL) Amyloidosis

Darzalex Faspro (daratumumab and hyaluronidase-fihj) is a combination of daratumumab (a CD38-directed cytolytic antibody) and hyaluronidase (an endoglycosidase) indicated for the treatment of multiple myeloma and light chain (AL) amyloidosis.

Development Timeline for Darzalex Faspro

Jan 15, 2021Approval  Darzalex Faspro (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
May  2, 2020Approval  FDA Approves Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Multiple Myeloma

Further information

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