It's only 5 minutes! Johnson & Johnson CD38 target anticancer drug darzalex subcutaneous injection type applied for listing in the European Union

July 22, 2019 / biool / - Janssen Pharmaceutical Company, a subsidiary of JNJ, an American pharmaceutical giant, recently announced that it has submitted an extension app license to the European Drug Administration (EMA) to approve the use of darzalex (daratumumab) for multiple myeloma (mm) patients The formulation was developed by enhanze drug delivery technology of halozyme company and contained recombinant human hyaluronidase PH20 (rhhuph20) In the European Union, darzalex is currently only approved for intravenous (IV) dosage forms In the middle of this month, Janssen Pharmaceutical also submitted a supplementary application for darzalex SC to the US FDA "This new formulation is an example of our unwavering commitment to seeking innovative treatment options to support patients with multiple myeloma," said Dr Patrick Laroche, head of Hematology therapy at Janssen pharmaceuticals Europe, the Middle East and Africa (EMEA) It is important that the efficacy of subcutaneous darzalex is comparable to that of existing intravenous preparations, and that it reduces the incidence of infusion related reactions, significantly reducing the time for patients to receive treatment, from a few hours to about five minutes " This application is based on the data of phase II clinical study pleeades (mmy2040) and phase III clinical study Columba (mmy3012) Results from the Columba study showed that darzalex SC and darzalex IV had non inferiority in efficacy (total remission rate: 41% vs 37%, ratio = 1.11, 95% CI: 0.89-1.37) and pharmacokinetics (daratumab Valley concentration [ctrough]: 499mg / ml vs 463mg / ml, ratio = 108%, 90% CI: 90% - 122%), and the administration time was shorter (5 minutes vs.122%) The incidence of transfusion related reactions was lower (13% vs 35%) Darzalex: the world's first McAb targeting CD30, with sales of US $2 billion in 2018 Darzalex is the first CD38 mediated and cytolytic antibody drug approved in the world It has broad-spectrum killing activity and can target the transmembrane extracellular enzyme CD38 which is highly expressed on the surface of multiple myeloma and multiple solid tumor cells It can induce the rapid death of tumor cells through a variety of immune-mediated mechanisms, including complementary dependent cytotoxicity (CDC) and antibody dependent fine Cell mediated cytotoxicity (ADCC), antibody dependent phagocytosis (ADCP) and apoptosis (apoptosis) In addition, darzalex has also been proved to be able to target immunosuppressive cells in tumor microenvironment to show immunoregulatory activity Darzalex was licensed by Janssen biotechnology from genmab in 2012 It is a product developed by Johnson & Johnson In addition to multiple myeloma, darzalex has the potential to treat other types of tumors with high expression of CD38 molecules, including diffuse large B cell lymphoblastic carcinoma (DLBCL) and chronic lymphoblastic leukemia CLL, all, PCL, AML, FL and MCL Darzalex was first approved for listing in November 2015, with sales exceeding $2 billion in 2018 At present, the drug has been approved for first-line and multi-line treatment of multiple myeloma in many countries around the world The specific approved indications are different in different countries, including: (1) as a single drug therapy, it has been used for at least three previous therapies (including a proteasome inhibitor [PI] and an immunomodulator [IMID]), or it has dual refractory to PI and immunomodulator (2) combination of lenalidomide and dexamethasone, or combination of bortezomib and dexamethasone, for MM adult patients who have received at least one treatment in the past; (3) combination of palmatidomide and dexamethasone, for MM adult patients who have received at least two treatments in the past, including lenalidomide and PI; (4) combination of bortezomib, melphalan and prednisone Prednisone, used in newly diagnosed mm adult patients who are not suitable for ASCT, makes darzalex the first McAb approved to treat newly diagnosed mm (5) The combination of lenalidomide and dexamethasone was used in newly diagnosed mm adult patients who were not suitable for ASCT In February this year, darzalex was approved by the U.S FDA This program will make a choice for medical and health professionals when they treat MM patients according to their needs The first intravenous infusion of darzalex will be divided into two consecutive days of intravenous infusion from a single infusion In addition, the FDA of the United States has accepted the supplementary application of darzalex combined with bortezomib, thalidomide and dexamethasone four drug regimen (d-vtd) for first-line treatment of patients with newly diagnosed mm in ASCT, and has granted priority review The application is also the first darzalex combination application for Johnson & Johnson to seek first-line treatment for newly diagnosed MM patients who meet ASCT conditions In the phase III Cassiopeia study, compared with the VTD group, the darzalex + VTD group had a significantly higher proportion of patients (42.4% vs 32.0%) who received severe complete remission (SCR) after induction and consolidation treatment Source of original text: Janssen seeks EMA approval for new subcutaneous formula of darzalex (daratumab)