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Johnson and Johnson (JNJ) Janssen Pharmaceuticals recently announced that the U.S. Food and Drug Administration (FDA) has approved Darzalex (SC) preparations - Darzalex Faspro (daratumumab and hyaluronid) ase-fihj, Daretoyu monoanti-hyaluronic acidase), in combined with boronitazome, cyclophosphamide, and dexamison (D-VCd program), for the treatment of newly diagnosed adult patients with light chain (AL) amyloid degeneration.
, the application of Darzalex SC for the treatment of the allergy is also being reviewed by the European Union.
AL amyloid is a rare and potentially fatal multi-system disease that occurs when an insoluble protein called amyloid accumulates in tissues and organs, interfering with healthy tissue and organ function.
, Darzalex Faspro is the first and only drug to treat AL amyloid degeneration.
clinical data showed a three-fold increase in hematological complete remission in patients receiving the D-VCd program (hemCR: 42% vs 13%, p<0.0001), and a continuous decrease in disease markers compared to patients receiving the commonly used treatment option VCd (boronzomi, cyclophosphamide, and dexamysund), indicating a deep hematological response.
Darzalex Faspro is a subsulational injection (SC) preparation for Darzalex ®.
Darzalex is the world's first CD38-mediated, soluble cellular antibody drug, the first FDA-approved monoclonal antibody drug to treat multiple myeloma (MM), its venous preparation (IV) was launched in 2015, has become the backbone of clinical treatment MM therapy, widely used in first-line, second-line, multi-line therapy.
Darzalex Subsulation Preparations (SCs) were approved for listing in the United States (product name: Darzalex Faspro) and the European Union (product name: Darzalex SC) in May and June 2020.
SC preparation in a fixed dose, under-the-skin injection, only 3-5 minutes to complete.
IV preparations are administered intravenously and can take several hours.
approval of SC preparations marks an important milestone in helping to positively change the lives of MM patients who rely on Darzalex treatment.
this new adaptation approval, based on data from the Phase III ANDROMEDA study.
This is the first randomized Phase III study to investigate newly diagnosed light chain (AL) amyloid degeneration patients treated with Darzalex subdernation agents (Darzalex Faspro) and assessed the efficacy and safety of darzalex-boratezomi-cyclophosphamide-D-VCd) and boronzomi-cyclophosphamide-desamisund.
VCd is a common treatment in newly diagnosed adult patients with AL amyloid degeneration.
data showed a three-fold increase in hematological complete remission in patients in the D-VCd treatment group (hemCR: 42% vs 13%, p<0.0001), and a continuous decrease in disease markers compared to the VCd treatment group, indicating a deep hematological response.
addition, the D-VCd group had a higher total hematological remission rate (92% vs. 77%) and a very good partial or better remission rate (≥VGPR: 79% vs 49%) compared to the VCd group.
compared to the VCd scheme, the D-VCd programme also extends the progress-free survival of major organ deterioration (MOD-PFS) and the event-free lifetime (MOD-EFS).
study, the safety of the combined drug was consistent with the safety of Darzalex off-cortical preparations or VCd.
Darzalex (Mega®): China's first CD38 targeted monoantigen, and then defined myeloma treatment Light Chain (AL) amyloid degeneration is a rare and potentially fatal multisyscular disease that occurs when the bone marrow produces abnormal antibody fragments called light chains (AL), which come together to form amyloid.
these amyloid proteins are deposited in tissues and vital organs, interfering with normal organ function.
with the development of the disease, many patients' hearts, kidneys, digestive tract, liver and nervous system and other organs gradually degraded.
diagnosis of AL amyloid degeneration is often delayed and the prognosis is poor due to the late onset of multi-organ (especially heart) suffering.
the medium survival of patients with AL amyloid is estimated to be between 6 months and 3 years, depending on the patient population and the data used.
currently, there is no approved treatment to treat this devastating disease.
Darzalex is the world's first CD38-mediated, lysolytic antibody drug with broad-spectrum killing activity that targets transcellular enzyme CD38 molecules that bind to multiple myelomas and multiple solid tumor cell surfaces. The mechanism of action of immuno-mediated induces rapid death of tumor cells, including complementary dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxic action (ADCC) and antibody-dependent cell phagocytosis (ADCP), and apoptosis.
, Darzalex has also been shown to be able to target immunosuppressive cells in tumor micro-environments to exhibit immunomodulation activity.
first approved for listing in November 2015, with sales of $2,998 million in 2019.
, the drug has been approved by many countries around the world for first-line, second-line, multi-line treatment of multiple myeloma.
In China, Darzalex (Mega®, Daretoyu monoantigen) was approved for market in October 2019 for single-drug treatment for adult patients with relapsed and refractic multiple myeloma, specifically for patients who have previously been treated with protease inhibitors and immunomodulants and who have progressed during the last treatment.
as China's first approved CD38 monoclonal antibody-targeted drug, this innovative program is expected to redefine the treatment of multiple myeloma in China.