Light chain (AL) amyloid degeneration first treatment! Johnson and Johnson Darzalex Faspro Apply for New Allergies: Hematological Remission Rate Up to 92%

September 11, 2020 // -- Johnson and Johnson (JNJ)'s Janssen Pharmaceuticals recently announced that it has filed a Supplemental Biologics Licensing Application (SBLA) with the U.S. Food and Drug Administration (FDA) seeking approval for Darzalex Faspro (daratumab and hyaluronidase-fihj, Daretoyu monoanti-hyalurase) for the treatment of light chain (AL) amyloidase patients.
is a rare and potentially fatal disease and there is no approved treatment.
if approved, Darzalex Faspro would be the first drug to treat AL amyloid degeneration.
, the sBLA is currently under review under the FDA's Real-Time Oncology Review (RTOR) program, which allows applicants to review data on certain applications before formally submitting a full application.
RTOR program aims to explore a more effective review process to ensure that patients receive treatment as quickly as possible.
addition, the sBLA is under review under the FDA's Oribis Program, an initiative launched by the FDA Center of Excellence for Oncology that provides a framework for the submission and review of oncology drug applications between international regulators.
Darzalex Faspro is a sub-cortective 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 intravenous 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 Subsartic Preparations (SCs) were approved for listing in the United States (commodity name: Darzalex Faspro) and the European Union (darzalex SC) in May and June this year.
SC preparations are given at a fixed dose and injected under the skin in just 3-5 minutes.
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 patient groups that rely on Darzalex treatment.
the sBLA based on the data from the Phase III ANDROMEDA study.
the study is the first randomized Phase III study to investigate newly diagnosed patients with light chain (AL) amyloid degeneration in Darzalex Faspro.
data show that Darzalex and CyBorD achieved a higher rate of complete hematological remission (CR: 53% vs. 18%, p.0001) compared to the cyclophosphamide-borontzomi-desemisson solution (D-CyBorD).
addition, the D-CyBorD program extends the progression-free survival of major organ deterioration (MOD-PFS) and the event-free lifetime (MOD-EFS) compared to the CyBorD program.
study, the safety of the combined drug was consistent with that of Darzalex off-the-skin preparations or CyBorD.
Darzalex (Mega®): China's first CD38 targeted monoantigen, and the definition of myeloma for the treatment of light chain (AL) amyloid 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.
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 plan to treat this devastating disease.
Darzalex is the world's first CD38-mediated, lysolytic antibody drug with broad-spectrum lethality and can target transcellular enzyme CD38 molecules that combine 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 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 in October 2019 for single-drug treatment of adult patients with relapsed and refractic multiple myeloma, specifically in 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.
() Original source: Janssen Submits Application Seeking U.S. FDA approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with With Light (AL) Amyloidosis.