Genmab Announces U.S. FDA Approval of Subcutaneous Formulation of Daratumumab, DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), for the Treatment of Patients with Multiple Myeloma
Genmab A/S - American Depositary Shares (GMAB)
Company Research
Source: GlobeNewswire
Company Announcement Subcutaneous formulation of daratumumab, DARZALEX FASPRO™, approved by the U.S. FDA for the treatment of patients with multiple myelomaApproval based on data from Phase III COLUMBA and Phase II PLEIADES studiesIn the studies, the fixed-dose subcutaneous formulation reduced treatment time from hours to minutes and demonstrated similar efficacy and safety with significantly fewer infusion-related reactions compared with the intravenous formulation Copenhagen, Denmark; May 01, 2020 – Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of the subcutaneous formulation of daratumumab, DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj). The Biologics License Application (BLA) for this formulation was submitted by Genmab’s licensing partner, Janssen Biotech, Inc. (Janssen) in July 2019. DARZALEX FASPRO is approved for the treatment of adult patients with multiple myeloma: in combination with bortezomib,
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