First line treatment does not accord with the transplantation of multiple myeloma! Darzalex + Rd three drug scheme of Johnson & Johnson blood cancer drug won favorable review in EU

October 23, 2019 / bioun / -- Johnson & Johnson's Janssen Pharmaceutical recently announced that the European Drug Administration (EMA) human pharmaceutical products Committee (CHMP) has issued a positive review opinion, suggesting to expand the existing marketing authorization of darzalex (daratumumab), including: the combination of darzalex with naduramine and dexamethasone for the three drug program (DRD), which is not in line with the autologous stem cells A newly diagnosed multiple myeloma (ndmm) patient with ASCT qualification The CHMP's comments will now be reviewed by the European Commission (EC), which is expected to make a decision within the next two months In the United States, the DRD three drug program was approved by FDA at the end of June this year for newly diagnosed MM patients who do not meet the ASCT conditions In the phase III study, DRD significantly reduced the risk of disease progression or death by 44% compared to lenalidomide plus dexamethasone The positive opinion of CHMP is based on the data of phase III clinical study Maia (mmy3008) This study was conducted in newly diagnosed MM patients who were not suitable for high-dose chemotherapy and ASCT, and evaluated the efficacy and safety of DRD compared with lenalidomide and dexamethasone The results were published in the New England Journal of Medicine (NEJM) and presented at the annual meeting of the American Society of Hematology (ash) in 2018 Data showed that median follow-up of 28 months showed that the study reached the primary end point of improving progression free survival (PFS): a preplanned mid-term analysis conducted by the independent data monitoring committee (IDMC) showed a significant 44% reduction in the risk of disease progression or death in the DRD group compared with the RD group (HR = 0.56, 95% CI: 0.43-0.73, P < 0.0001) The median PFS in the DRD group was not reached, and the median PFS in the RD group was 31.9 months In addition, compared with RD, DRD achieved a deeper level of remission, including improved complete or better remission rate (48% vs 25%), and overall remission rate (93% vs 81%) In the study, the most common 3 / 4-stage adverse events (≥ 10%) in the DRD group included neutropenia (50%), lymphopenia (15%), pneumonia (14%) and anemia (12%) 41% of the patients had transfusion related reactions, 3% of them were grade 3 / 4 The security of darzalex is consistent with previous studies 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 According to the 2018 performance report released by Johnson & Johnson, darzalex's global sales in 2018 reached US $2.025 billion (2017: US $1.242 billion, an increase of 63.0%), including US $1.203 billion (2017: US $1.203 billion, an increase of 36.1%), and international sales of US $822 million (2017: US $358 million, an increase of more than 100%) Evaluatepharma, a pharmaceutical market research firm, predicted that darzalex's global sales in 2024 would reach US $6.033 billion, and that the drug would also become a key product for Johnson & Johnson's future growth Source of original text: CHMP grants positive operation for expanded use of Janssen's darzalex (daratomab) for patients with newly diagnosed multiple myeloma who are transform incoming