On June 4, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported 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 (Press release, Halozyme, JUN 4, 2020, View Source [SID1234560834]). 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.
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"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."
The 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) (Free ASCO Whitepaper) Annual Meeting and the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress. Updated data of the COLUMBA and the PLEIADES studies were presented during poster sessions at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2019.
About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.