Darzalex (daratumumab), a new anticancer drug developed by American pharmaceutical giant Johnson & Johnson (JNJ), has received good news in EU regulation. The European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) supports conditional approval of Darzalex for relapse or difficulty in treatment that has been previously treated (including a protease inhibitor PI and immunomodulator IMiD) and worsened after treatment. Treatment of multiple myeloma (MM) in adults. Earlier, Darzalex was approved by the US FDA in November 2015. The drug is the first monoclonal antibody drug approved by the FDA for the treatment of multiple myeloma (MM).
CHMP's positive opinion is based on data from two open clinical studies. In the first study, 106 patients were treated with Darzalex, and 29% of patients experienced complete or partial tumor shrinkage, which lasted an average of 7.4 months. In the second study, 42 patients were treated with Darzalex, and 36% of patients experienced complete or partial tumor shrinkage. In the study, the most common side effects of Darzalex treatment were infusion-related reactions, fatigue, fever, cough, nausea, back pain, upper respiratory tract infection, anemia, neutropenia, and thrombocytopenia.
Daratumumab is an oncology product developed by Johnson & Johnson. The company signed a $1.1 billion agreement with Genmab in 2012 to acquire the exclusive rights of daratumumab. At the end of 2014, the two sides further expanded daratumumab cooperation, launched a phase II clinical project, and investigated daratumumab monotherapy for three different types of non-Hodgkin's lymphoma (DLBCL, FL, MCL). In early 2015, Johnson & Johnson reached a partnership with the famous biopharmaceutical company Halozyme to develop a subcutaneous injection form of daratumumab. Halozyme is a leader in subcutaneous drug delivery. The company has successfully developed a variety of subcutaneous injections of heavyweight monoclonal antibodies with pharmaceutical giants such as Roche, Baxter and Pfizer.
Daratumumab is a humanized anti-CD38 monoclonal antibody with broad-spectrum killing activity, targeting the transmembrane extracellular CD38 molecule, which is highly expressed on the surface of multiple myeloma cells, and can induce rapid death of tumor cells through various mechanisms. . Currently, daratumumab is in five clinical phase III studies. In addition to multiple myeloma, daratumumab also has the potential to treat other types of tumors that express CD38 molecules, including: diffuse large B-cell lymphoma (DLBCL), chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), plasma cells. Leukemia (PCL), acute myeloid leukemia (AML), follicular lymphoma (FL), and mantle cell lymphoma (MCL). (Bio Valley Bioon.com)
About multiple myeloma:
Multiple myeloma (MM) is a plasma cell carcinoma found in the bone marrow. In multiple myeloma, a group of plasma cells (or myeloma cells) are transformed into cancer cells and proliferate, resulting in a higher than normal number of plasma cells. Because plasma cells migrate extensively in the body, it may affect most bones in the body, which may lead to compression fractures, osteolytic lesions and related pain. Multiple myeloma can cause several serious health problems, involving red blood cell counts in the bones, immune system, kidneys, and individuals. Some of the more common symptoms include bone pain and fatigue, and fatigue is a symptom of anemia. Multiple myeloma is a rare cancer, with an annual incidence of approximately 20,000 in the United States and approximately 114,000 worldwide.
We're Professional Supplier Extract Powder manufacturers and suppliers in China specialized in providing high-quality products at low price. We warmly welcome you to buy or wholesale bulk Supplier Extract Powder for sale here from our factory. For a free sample, contact us now.
Supplier Extract Powder,Supplier Extract ,Supplier Powder Manufacturer in China
Shaanxi Kang New Pharmaceutical co., Ltd. , https://www.apipepdites.com