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Halozyme Announces Janssen Receives European Marketing Authorization For Subcutaneous DARZALEX® Utilizing Halozyme's ENHANZE® Technology For The Treatment Of Patients With Multiple Myeloma
- Approval Follows Positive Opinion by European Committee for Medicinal Products for Human Use (CHMP) in April 2020 and Applies to All Current IV DARZALEX®
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"- Approval Follows Positive Opinion by European Committee for Medicinal Products for Human Use (CHMP) in April 2020 and Applies to All Current IV DARZALEX® Indications in Frontline and Relapsed/Refractory Settings -\n - Innovative, Fixed-dose Subcutaneous Formulation with ENHANZE® Demonstrates Consistent Efficacy to Intravenous DARZALEX® with Lower Rate of Infusion-related Reactions -\n\n\nSAN DIEGO, June 4, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the European Commission (EC) has granted Janssen-Cilag International NV (Janssen) marketing authorization for the subcutaneous (SC) formulation of DARZALEX® (daratumumab), for the treatment of adult patients with multiple myeloma in all currently approved DARZALEX® intravenous (IV) formulation indications in frontline and relapsed / refractory settings. The approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in April 2020. The SC formulation is administered as a fixed-dose over approximately three to five minutes, significantly less time than IV DARZALEX®, which is given over several hours. Patients currently on IV DARZALEX® will have the choice to switch to the SC formulation. \n\"We are delighted that the subcutaneous formulation of DARZALEX® has been granted marketing authorization in the EU with a broad label so soon after the CHMP positive opinion,\" said Dr. Helen Torley. \"DARZALEX® SC has the potential to improve the treatment experience for multiple myeloma patients and physicians in the European Union as patients may benefit from a shorter treatment time when compared with a multi-hour intravenous infusion.\"\nThe approval was based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the SC formulation of daratumumab to the IV formulation in patients with relapsed or refractory multiple myeloma, and data from the Phase II PLEIADES (MMY2040) study, which evaluated SC daratumumab in combination with certain standard multiple myeloma 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 24th European Hematology Association (EHA) Annual Congress. Updated data of the COLUMBA and the PLEIADES studies were pr...