What class of drug is daratumumab?
Daratumumab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.
Is daratumumab an immune checkpoint inhibitor?
Daratumumab is another drug that has an immunomodulatory effect in MM and can potentially augment the therapeutic benefit of immune checkpoint inhibitors.
Is daratumumab an immunotherapy?
Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Is daratumumab a monoclonal antibody?
Daratumumab (Darzalex[TM]) is a human monoclonal antibody (MAb) that targets CD38; a surface protein highly expressed across multiple myeloma (MM) cells.
Is daratumumab a biologic?
The FDA has approved Darzalex in combination with Takeda’s Velcade, thalidomide and dexamethasone (VTd) for new patients who are eligible for stem cell transplant, making it the first biologic regimen for this patient population.
Does daratumumab cause neutropenia?
Grade 3–4 neutropenia was recorded in 5–12% of patients receiving single-daratumumab according to phase 1–2 trials [1, 2]. Although neutropenia was more common in daratumumab triplet therapy, the addition of daratumumab did not significantly increase documented infections and treatment discontinuation [3, 4].
How long does it take for Daratumumab to work?
Treatment durations of up to 25 months have been reported in clinical trials (range 0.1 month to 40.44 months). Research suggests people with IgG MM may be more responsive to Darzalex treatment. In clinical trials, it took approximately one month for Darzalex to start working.
Does daratumumab cause neuropathy?
In this pooled safety population, the most common adverse reactions (≥20%) were upper respiratory infection, neutropenia, infusion-related reactions, thrombocytopenia, diarrhea, constipation, anemia, peripheral sensory neuropathy, fatigue, peripheral edema, nausea, cough, pyrexia, dyspnea, and asthenia.
Is daratumumab cytotoxic?
Preclinical studies showed that daratumumab may kill myeloma cells by complement-mediated cytotoxicity, by antibody-dependent cellular cytotoxicity, and by antibody-dependent cellular phagocytosis (1–3).
Is daratumumab anti CD38?
Daratumumab (Dara) is the first-in-class human-specific anti-CD38 mAb approved for the treatment of multiple myeloma (MM). Although recent data have demonstrated very promising results in clinical practice and trials, some patients do not achieve a partial response, and ultimately all patients undergo progression.
How effective is daratumumab?
Daratumumab, Lenalidomide, and Dexamethasone The overall response rate was 81%, with 34% of patients achieving a complete response or better and 63% achieving a very good partial response (VGPR) or better. The median response duration was not reached, and 91% of patients were free of disease progression at 12 months.
Does daratumumab cause insomnia?
The most common adverse reactions (≥20%) were upper respiratory tract infection, constipation, nausea, fatigue, pyrexia, peripheral sensory neuropathy, diarrhea, cough, insomnia, vomiting, and back pain.
What is the mechanism of action of daratumumab?
Mechanism of action Daratumumab is an IgG1k monoclonal antibody directed against CD38. CD38 is overexpressed in multiple myeloma cells. Daratumumab binds to a different CD38 epitope amino-acid sequence than does the anti-CD38 monoclonal antibody isatuximab.
How does daratumumab bind to the CD38 epitope?
Daratumumab binds to a different CD38 epitope amino-acid sequence than does the anti-CD38 monoclonal antibody isatuximab. Daratumumab binds to CD38, causing cells to apoptose via antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, inhibition of mitochondrial transfer or antibody-dependent cellular phagocytosis.
When was daratumumab approved for multiple myeloma?
Daratumumab is an immunoglobulin G1 kappa monoclonal antibody developed by Janssen and Genmab. 1 It was first described in the literature in 2010 as a monoclonal antibody that targets CD38+ multiple myeloma cells; the first of its kind. 5 Daratumumab was granted FDA approval on 16 November 2015. 6
Can a daratumumab injection cause CMV reactivation?
Daratumumab frequently causes human cytomegalovirus (CMV) reactivation by an unknown mechanism. Injection related reactions (inflammation-like) are also common. Daratumumab can also bind to CD38 present on red blood cells and interfere with routine testing for clinically significant antibodies.