The administration is only 3-5 minutes! Johnson and Johnson Darzalex (megacopic ®) subcutaneous preparation myeloma Phase III Clinical Success: Significantly Prolonged Progression Survival!

!--webeditor: "page title" -- 2020 -0220 /PRNewswire/ -- Johnson and Johnson Pharmaceuticals Inc. (JNJ) and the European Myeloma Network (EMN) have announced the release of myeloma drug Darzalex (Mega®, generic name: dardar Positive results from the study of APOLLO (MMY3013, NCT03180736) of the subcutaneous (SC) preparation for the treatment of relapsed or refractive multiple myeloma (R/R MM) PHASE III APOLLO (MMY3013, NCT03180736).
Darzalex is the world's first approved CD38 mediated, lysozymatic antibody drug, the United States FDA approved the first treatment of multiple myeloma (MM) monoclonal antibody drug, its intravenous preparation (IV) was listed in 2015, has been approved by many countries around the world for first-line, second-line, multi-line treatment MM, has become the backbone of clinical treatment MM therapy.
's subcutaneous preparations (SC) were approved for listing in the US (Darzalex Faspro) and the European Union (Darzalex SC) in May and June this year.
SC preparations are administered in fixed doses and subcutaneous injections in just 3-5 minutes.
and IV preparations are administered intravenously, which can take several hours. the approval of the
SC preparations marks an important milestone in the positive change in the lives of MM patients who rely on Darzalex for treatment.
clinical 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%).
APOLLO is a random, open-label, multicenter study that enrolled 304 r/R MM patients previously treated with naratine (an immunomodulator, IMiD) and a protease inhibitor (PI).
study, patients were randomly divided into 2 groups at 1:1, and were treated with Darzalex SC and Pomadomine and Pd, respectively.
in the initial study design, patients in the Darzalex-Pd group were treated with Darzalex IV preparations.
since the revised design, all new subjects in the experimental group used Darzalex SC preparations. The primary endpoint of
study is Progressless Survival (PFS).
the study was conducted in Europe under the agreement of Jansen, EMN and the Netherlands Working Group on Adult Blood Tumors (HOVON).
results showed that the study reached the main end point: compared with the Pd group, the Darzalex-Pd group significantly improved in PFS.
safety, overall, the safety of Darzalex SC-Pd's combination drug regimen is consistent with the safety of each drug in the program.
2012, Jansen obtained a global exclusive license to develop, manufacture and commercialize Daratumab from Genmab.
the company intends to discuss the data with regulators in preparation for regulatory submissions, and plans to publish the full data at an upcoming medical conference.
APOLLO study to confirm the results of the Phase I EQUULEUS (MMY1001) study, which looked at intravenous (IV) Darzalex-Pd programmes under the same indications.
June 2017, the FDA approved the combined application of Darzalex-Pd for treatment of R/R MM patients who have previously received at least two treatments, including lenamines and PI.
Darzalex (Mega®, Daretou monosar) china's first CD38-targeted monosar, and then defined myeloma for the treatment of multiple myeloma (MM) is an incurable blood cancer that begins with the bone marrow and is characterized by excessive proliferation of plasma cells.
the disease is the third most common blood cancer in the United States, after leukemia and lymphoma.
estimate s160,000 people worldwide will be diagnosed with the disease and 106,000 will die from the disease in 2018.
Although some MM patients have no symptoms at all, most are diagnosed with related symptoms, including: bone problems, low blood cell counts, calcium increases, kidney problems, or infections.
Darzalex is the world's first approved CD38 intermediated, lysozymatic antibody drug with broad-spectrum lethal activity, can target trans-diaphmo CD38 molecules combined with multiple myeloma and a highly expressed surface of multiple solid tumor cells, through a variety of immune mediated The mechanismof guidance induces rapid death of tumor cells, including complementary-dependent cytotoxicaction (CDC), antibody-dependent cell-mediated cytotoxic action (ADCC), and antibody-dependent cell phagocytophapharycation (ADCP), as well as apoptosis through apoptosis.
, Darzalex has been shown to exhibit immunomodulation activity by targeting immunosuppressive cells in tumor microenvironments.
Darzalex was first approved for listing in November 2015 and has sales of $2,998 million in 2019.
currently, the drug has been approved by several countries around the world for first-line, second-line, multi-line treatment of multiple myeloma, specific approved indications vary in different countries.
in the United States, the drug has been approved: (1) as a single drug therapy, used in the past to receive at least three therapies (including a protease inhibitor (PI) and an immunomodulator (IMiD)) or MM adult patients with dual incurability to PI and IMiD; (2) in November 2016, combined with nadomine and dexamethasone, or combined boratizomi and dexamethasone, for previous treatments Adult mm patients; (3) in June 2017, combined pomadomine and dexamethasone, for MM adult patients who have previously received at least 2 treatments, including indomine and PI; The approval of Darzalex became the first monoantiphobic drug approved for new treatment of MM for an indoctris stem cell transplant (ASCT) for newly diagnosed MM patients, combined boratizomi, melphalan and prednisone.
(5) June 2019, combined with nadomidamine and dexamethasone for use in newly diagnosed MM adult patients who are not suitable for ASCT.
(6) September 2019, combined boratizomi, thalidomide and dexamethasone for use in adult patients with new ASCT treatments, the approval makes Darzalex the first biological agent approved for use in new MM patients eligible for ASCT.
!--/ewebeditor:!--webeditor:page title" -- In February 2019, a sub-administered drug program from Darzalex was approved by the U.S. FDA.
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.
May 2020, Darzalex Faspro was approved by the U.S. FDA to cover four options for five protocols for the therapy, including new MM patients, MM patients who do not qualify for ASCT transplants, relapsed or refracted MM patients.
in China, Darzalex (®, Daretousaum) was approved for the market in October 2019 for single-drug treatment for patients with recurrent and refractory multiple myeloma, specifically in patients who have previously been treated with protease inhibitors and immunomodulators and developed disease progression during the last treatment.
as China's first approved CD38 monoclonal antibody target drug, an innovative program that promises to define the treatment of multiple myeloma in the country. original source of
() Genmab Announces European Myeloma Network and Janssen Achieve Positive Topline Results Phase 3 APOLLO Study of Daratumab in Combination with Pomalidomide and Dexamethasone in Lapsrereor Ielo !--ma