The administration is only 3-5 minutes! Johnson and Johnson Darzalex (megazo ®) subcutaneous preparation has been approved by the European Union: the first myeloma subcutaneous CD38 target anti-cancer drug!
Last Update: 2020-06-17
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, 2020 /
PRNewswire/ -- The European Commission (EC) recently approved The Johnson and Johnson (JNJ) heavy myeloma drug Darzalex ,®, generic name: daratumab, Darree Subcutaneous (SC) preparations for the treatment of adult patients with multiple myeloma (MM) are approved for all currently approved therapeutic indications, including first-line treatment and recurrent/refractive disease treatmentDarzalex SCadministered in a fixed dose, by subcutaneous injection,can be done in 3-5 minutes to complete theIV preparationsadministered intravenously, often taking hoursThe approval of the SC preparation marks an important milestone in the positive change in the lives of MM patients who rely on Darzalex for treatmentPatients currently receiving IV preparations may choose to switch to SC preparations for treatmentnoteworthy, Darzalex SC preparations are the only regulatoryly approved drugs for the treatment of MM cd38 targeted antibodyIn the United States, Darzalex SC preparations were approved in May this year under the brand name Darzalex Faspro (Daratumumab and hyaluronidase-fihj), daretoumono-hyaluronic acid asse, which was approved by theFDAfor four options covering 5 therapeutic indications, including MM patients with newdiagnosis, MM patients who do not qualify for transplantation, patients who do not qualify for transplantation, or patients with relapses or difficulty in treating MMclinical data show that Darzalex SC preparations have consistent efficacy and pharmacokinetics and similar safety compared to Darzalex IV preparations, significantly reduce treatment time (from hours to 3-5 minutes), and reduce the incidence of systemic administration-related reactions (ARR) by two thirds (13% vs 44%) this approval, based on efficacy and safety data for Phase III Clinical Research COLUMBA (MMY3012) and Phase II Clinical Study PLEIADES (MMY2040) - COLUMBA is a random open-label study that compared the non-effectiveness of Darzalex SC and Darzalex IV for single-drug therapy in mm patients who had previously received at least three treatment options (including protease inhibitors (PI), immunomodulators (IMiD) or MM patients who were difficult to treat both PI and IMiD results show that Darzalex SC and Darzalex IV preparations are in efficacy (total mitigation rate: 41% vs 37%, ratio of 1.11, 95% CI: 0.89-1.37) and pharmacokinetics (Daratumumab Valley Concentration: 499 mg/mL vs 463mg/mL, ratio of 108%, 90% CI: 90%-122%) has non-poor efficacy, while shorter administration time (5 minutes vs 3 hours or more), systemic administration-related reactions (ARR) have a lower incidence (13% vs 34%) - In 490 cases of summary safety of Darzalex SC preparations as single-drug or combination therapy, the incidence of ARR was 11% Darzalex IV preparations are similar to darzalex SC preparations in other aspects of the safety profile -Phase II PLEIADES study evaluated the efficacy and safety of Darzalex SC preparations in combination therapy In mm patients who were not eligible for transplantation in the new diagnosis , the efficacy of the Darzalex SC preparation and the combination drug regimen (D-VMP) of boratyzomi,mafarin-perison were confirmed In addition, the efficacy of Darzalex SC preparations and the combination of dilatedamine and dexamethasone (D-Rd) was also confirmed in patients with relapsed or refractive MM who had previously received a treatment regimen Darzalex (Mega®, Daretou monosartag): China's first CD38 targeted monosar, and then defined myeloma treatment in China, Darzalex (mega®, Daretoumono) was approved for the market in October 2019, the drug is suitable for single-drug treatment in adult patients with recurrent and refractory multiple myeloma, specifically: patients who have received a protein inhibitor and immunotherapy As China's first approved CD38 monoclonal antibody-targeted drug, the innovative program is expected to define the treatment of multiple myeloma in the country Darzalex is the world's first approved CD38 intermediated, lysozymatic antibody drug with broad-spectrum anti-personnel activity, can target trans-diaphytic extmosome CD38 molecules combined with multiple myeloma and a highly expressed surface of a variety of solid tumor cells, through a variety of immune mediated The mechanisms of action induce rapid death of tumor cells, including complementary-dependent cell toxicity (CDC), antibody-dependent cell-mediated cytotoxicaction (ADCC) and antibody-dependent cell phagocytopha (ADCP), as well as the (apoptosis) through In addition, Darzalex has been shown to target immunosuppressive cells in tumors microenvironments to show immunomodulation Darzalex was first approved for listing in November 2015 and has sales of $2,998 million in 2019 At present, the drug has been approved by several countries around the world for first-line, second-line, multi-line treatment of multiple myeloma, specifically approved indications vary from country to country, including: (1) November 2015, as a single drug therapy, used in the past has received at least 3 types of Therapy (including a protease inhibitor (PI) and an immunomodulator (IMiD)) or mm adults with dual refractory to PI and immunomodulators; Semisone, or combined boratizom and dexamethasone, used in MM adult patients who have previously received at least one therapy; In adult MM patients with therapy (including lenadoamine and PI); (4) may 2018, co-boratizomi, melphalan and prednisone are not suitable for self-
The approval of the new MM adult patient with transplantation (ASCT) makes Darzalex the first monoanti-drug approved for the treatment of new mm (5) In June 2019, a combination of nadoamine and dexamethasone for use in newly diagnosed MM adult patients not suitable for ASCT (6) In September 2019, combined boratizomi, thalidomide and dexamethasone were used for new ADULT patients with ASCT, making Darzalex the first biological agent approved for use in newly diagnosed MM patients eligible for ASCT February 2019, a sub-administered drug program from Darzalex was approved by the U.S FDA The program will allow healthcare professionals to choose as needed when treating MM patients, dividing Darzalex's first intravenous infusion from a single one-time infusion into two consecutive days of intravenous infusions (BioValleyBioon.com) original origin: Subcutansheic of J.J.s Darzalex OK'd in Europe
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