The administration is reduced from 3 hours to 5 minutes! Johnson and Johnson's heavy CD38 target anti-cancer drug Darzalex (mega-®) subcutaneous injection preparation Japan applies for listing!

April 27, 2020 /
Biovalley BIOON/ -- Jansen Pharmaceuticals Inc., part of Johnson and Johnson (JNJ), recently submitted a new drug application (NDA) to the Ministry of Health, Labor and Welfare (MHLW) of Japan, seeking approval of Darzalex (Mega®, general name: Daratumumumum, Daretou ubichen) pizzelist injection (SC) formulation for the treatment of multiple myeloid (MM) patients The dosage form is developed using Halozyme's ENHANZE drug delivery technology and contains recombinant human hyaluronic acidase PH20 (rHuPH20) In July 2019, Jansen Pharmaceuticals also filed a supplementary application for Darzalex SC to the U.S FDA and the European Union's EMA Darzalex products are currently on the market as intravenous (IV) preparations this new dosage form is an example of Johnson and Johnson's unwavering commitment to finding innovative treatments to support patients with multiple myeloma Importantly, the efficacy of Darzalex SC preparations was comparable to that of existing IV formulations and reduced the incidence of infusion-related reactions, significantly reducing the time it takes for patients to receive treatment, from a few hours to about 5 minutes this application, based on data from the Phase II clinical study PLEIADES (MMY2040) and Phase III Clinical Research COLUMBA (MMY3012) COLUMBA is a random open label study that compared the non-adverse efficacy of Darzalex SC and Darzalex IV in patients who had previously received at least three treatment options (including protease inhibitors (PI), immunomodulators (IMiD) or multiple myeloma patients who had difficulty treating PI and IMiD results show that Darzalex SC and Darzalex IV are in effect (total mitigation rate: 41% v 37%, ratio: 1.11,95% CI: 0.89-1.37) and pharmacokinetics (Daratumumgrain Valley Concentration s.C.: 4 99mg/mL v 463mg/mL, ratio of 108%, 90% CI: 90%-122%) has non-adverse effect, while administration time is shorter (5 minutes v 3 hours or more), the incidence of infusion-related reactions is lower (13% v 35%) Darzalex (Mega®, Daretou monoantigen): China's first CD38 target monoantigen, and then define myeloma treatment in China, Darzalex (Mega®, Daretau monoantigen) was approved in October 2019, the drug is suitable for single-drug treatment of recurrent and refractory multiple myeloma adult patients, specifically: previously received protein inhibitors and immunotherapy treatment of the last treatment of the disease As China's first approved CD38 monoclonal antibody target drug, this innovative program promises to redefine the treatment of multiple myeloma in China Darzalex is the world's first approved CD38 mediated, cysotostic antibody drug with broad-spectrum killing activity, which can target cross-membrane extracellular enzyme CD38 molecules that bind to multiple myeloma and highly expressed on the surface of multiple solid tumor cells, through a variety of immunomediated The mechanism of action induces rapid death of tumor cells, including complementary dependent cell toxicity (CDC), antibody-dependent cell-mediated cytotoxic action (ADCC), and antibody-dependent cell phagocytosis (ADCP), as well as through apoptomy (apoptoi) In addition, Darzalex has been shown to target immunosuppressive cells in the tumor microenvironment to demonstrate immunomodulatory activity Darzalex was first approved for the market in November 2015, with sales of $2.998 billion in 2019 Currently, the drug has been approved by several countries around the world for first-, 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 to receive at least 3 Therapy (including a protease inhibitor (PI) and an immunomodulator (IMiD)) or mm patients with double incurable treatment of PI and immunomodulators; Dexamethasone, or combined boronitezomi and dexamethasone, for MM adult patients who have received at least one treatment in the past; (3) June 2017, united with Pamaduamine and dexamethasone, for previously accepted at least 2 Mm adult patients with therapy (including Renae amine and PI) and (4) May 2018, combined with boronzomi, melphalan, and prednione, for use in stem cells not suitable for self-
The approval of a new transplant for MM adult patients, this approval makes Darzalex the first single anti-drug approved for the treatment of the new MM (5) In June 2019, a combination of naldosin and dexamethasone is used for new MM adult patients who are not suitable for ASCT (6) In September 2019, combined boronzomi, salidoamine and dexamethasone for new MM patients suitable for ASCT, this approval makes Darzalex the first biological agent to be approved for ASCT-eligible new patients February 2019, Darzalex's sub-administration program was also The FDA approved The program will provide healthcare professionals with a choice as needed when treating MM patients, dividing Darzalex's first intravenous infusion from a single one-time infusion into two consecutive days of intravenous infusion in February, Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson, to the United States The FDA price increase in a supplementary biologics licensing application (BLA) seeking approval for Darzalex's combination with Kyproli (carfilzomib, Cafizomib) and Dysemisson (DKd) for the treatment of patients with recurrent or refractory multiple myeloma (R/R MM) The BLA is based on the results of phase III CANDOR study (NCT03158688) It is worth noting that this is the first Phase III study to combine the two key mechanisms of the drug Darzalex (anti-CD38 monoantigen) and Kyproli (protease inhibitor) for the treatment of multiple myeloma (MM) Data show that the median follow-up 17 months, the study reached the main endpoint of no progression (PFS): compared to the KdD treatment group, the risk of disease progression or death significantly reduced by 37% (HR -0.630; 95% CI: 0.464, 0.854; p.0.0014) The bit PFS in the Kdd treatment group was 15.8 months, and the bit PFS in the KdD treatment group had not yet reached In addition to reaching the primary endpoint, KdD also showed significant efficacy in key secondary endpoints compared to Kd, including: ORR (84.3% v 74.7%, p.0040), MRD-Full Remission Rate at 12th month of treatment (1 2.5% v 1.3%, up nearly 10 times, p 0.0001), OS (2 counties are not reached, HR s 0.75; 95% CI: 0.49, 1.13; p.08) In the study, the safety of the KdD scheme was consistent with the known safety of each drug in the scheme Currently, Darzalex and Kyproli have become important basic therap
ies for the treatment of multiple myeloma (MM) The results from the CANDOR study provide strong evidence that The KdD protocol treats patients with recurrent diseases with deep and long-lasting remission The combination of Kypropri (protease inhibitor) and Darzalex (anti-CD38 monoantigen) is a very promising new method for treating patients with recurrent or refractory multiple myeloma (BiovalleyBioon.com) original source: Halozy Announceme Janen New Drug app
lication In Japan For Daratumab Subcutaneou UtilizIng Halozyme' ENHANZE Technology® For Patient With Patient Multiple Myelo