Jansen Pharmaceuticals submits Darzalex (Daratumumab) Class II change request to EMA

recently, Johnson and Johnson's JanssenPharmaceutical(http://announced a Class II change application to the EuropeanDrug(http://Authority (EMA) for approval of darzalex (Daratumab) in conjunction with the DRRd, for new patients with multiple myeloma (MM) who are not suitable for self-contained stem cell transplants (ASCT)The application is based on data from Phase III clinical study MAIA (MMY3008)The study, conducted in newly diagnosed MM patients who are not suitable for high-dose chemotherapy and ASCT, assessed the efficacy and safety of the DRd protocol relative to the Inamine and Dexamethasone ii Drug (Rd) protocolData show that, with 28 months of median follow-up, the study reached a major endpoint for improving progressionless life (PFS): a pre-planned mid-
analysis by the Independent Data Monitoring Committee (IDMC)(http://showed a significant 44% reduction in the risk of disease progression or death in the DRd treatment group compared to the Rd treatment group (HR -0.56,95% CI: 0.43-0.0001, p 0.0001)The pfS in the DRd treatment group was not yet reached, and the median PFS in the Rd treatment group was 31.9 monthsIn addition, DRd achieved deeper mitigation than Rd, including an increased full or better mitigation rate (48 percent vs 25 percent) and an increase in the overall mitigation rate (93 percent vs 81 percent)Instudies, the most common adverse events in the DRd treatment group in stage 3/4 (-10%) included neutropenomic cell reduction (50%), lymphatic reduced (15%), pneumonia (14%) and anemia (12%)Forty-one percent of patients had infusion-related reactions, of which 3 percent were in the 3/4 levelDarzalex's security is consistent with previous studiesAbout Darzalex
Darzalex is the world's first approved CD38 mediated, cytometoplatic 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 apoptosisIn addition, Darzalex has been shown to target immunosuppressive cells in tumor microenvironments to demonstrate immunomodulatory activityDarzalex was granted global exclusive rights by Jansen Biotechnology in 2012 as aproduct(http://developed by Johnson and Johnson, and in addition to multiple myeloma, Darzalex has the potential to treat other types of tumors with highly expressed CD38 molecules, including Diffuse large B-cell lymphocarcinoma (DLBCL), chronic lymphocytic leukemia (CLL), acute lymphocytic leukemia (ALL), plasma cell leukemia (PCL), acute myeloid leukemia (AML), opified lymphoma (FL) and set cell lymphoma (MCL), etc