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

Company Announcement

• Subcutaneous formulation of daratumumab, DARZALEX FASPRO, approved by the U.S. FDA for the treatment of patients with multiple myeloma
• Approval based on data from Phase III COLUMBA and Phase II PLEIADES studies
• In 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, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT); in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. DARZALEX FASPRO is a fixed-dose formulation that can be administered over approximately three to five minutes, significantly less time than intravenous DARZALEX, which is given over several hours. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

The approval was based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the subcutaneous formulation of daratumumab to the intravenous formulation in patients with relapsed or refractory multiple myeloma and data from the Phase II PLEIADES (MMY2040) study, which is evaluating subcutaneous daratumumab in combination with different standard multiple myeloma treatment regimens. The topline results from the COLUMBA study were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and the 24^th European Hematology Association (EHA) Annual Congress. An update of the COLUMBA data as well as data from the PLEIADES study were presented during poster sessions at the 61^st American Society of Hematology (ASH) Annual Meeting in December 2019.