European Commission approves split dose scheme for Johnson and Johnson Darzalex

, the European Commission (EC) has approved Darzalex's split dose plan, the, ahttp:// company owned by the u.Spharmaceutical(http:// http://
)giant,, announcedthe program will provideMedical(http://health professionals with the option to treat patients with multiple myeloma (MM), dividing Darzalex's first infusion from a single one-time infusion into two consecutive days of infusionAbout Darzalex
Darzalex is the world's first approved CD38 mediated, cysototic antibodydrug(http://with broad-spectrum killing activity that targets transmembrane extracellular CD38 molecules that bind multiple myeloma and highly expressed on the surface of multiple solid tumor cells Rapid death of tumor cells is induced through a variety of immunomediated mechanisms, including complementary dependent cell toxicity (CDC), antibody-dependent cell-mediated cytotoxic action (ADCC), and antibody-dependent cell phagocytosis (ADCP), and apoptosis through apoptosis In addition, Darzalex has been shown to target immunosuppressive cells in tumor microenvironments to demonstrate immunomodulatory activity 　　Darzalex is a product developed by Johnson and Johnson (http:// , in addition to multiple myeloma, Darzalex also has the potential to treat other types of tumors with highly expressed CD38 molecules, including diffuse large B-cell lymphoma (DLBCL), chronic lymphocytic leukemia (CLL), acute lymphocytic leukemia (ALL), plasma leukemia (PCL), acute myeloid leukemia (AML), l.a 　The approval for the EQUULEUS is based on data from the Ib clinical study EQUULEUS (MMY1001) study showed that Darzalex pharmacokinetic concentrations were comparable in the treatment of patients with multiple myeloma, whether the first dose was a batch infusion or a single one-time infusion In the study, the safety of Darzalex infusions or single-use infusions was comparable in Europe, Darzalex's current indications are: (1) combined bortezomib, a protease inhibitor (PI), melphalan, and prednisone, for new MM adult patient s not suitable for self-contained stem cell transplantation (ASCT); In adult patients with recurrent and refractory MM who received a variety of drugs (including a protease inhibitor (PI) and an immunomodulator (IMiD)) and received the last drug; (3) combined with nala and dexamethasone, or combined with bobutylandandand and dexamethasone, for MM adult patients who had previously received at least one therapy