Release date: 2015-11-23
On November 16, the FDA accelerated the approval of Darzalex (daratumumab) for patients with multiple myeloma who had received at least three previous treatments. Darzalex is the first monoclonal antibody approved for the treatment of multiple myeloma. There is currently no effective treatment for multiple myeloma on the market, so the approval of daratumumab will undoubtedly bring a glimmer of hope to many patients.
Extend a little common sense:
Daratumumab is an IgG1k antibody, a humanized anti-CD38 monoclonal antibody with broad-spectrum killing activity, targeting transmembrane extracellular CD38 molecules that are highly expressed on the surface of multiple myeloma cells, and can induce tumor cells through various mechanisms. The rapid death. Since healthy cells and all myeloma cells express CD38, drug toxicity needs to be fully considered.
Gossip about the application process:
Daratumumab is an oncology product developed by Johnson & Johnson. The FDA granted daratumumab a breakthrough drug qualification for multiple myeloma (MM) in May 2013, which is the second honorable breakthrough drug qualification in the company's oncology pipeline. Product. In view of the fact that the clinical condition of patients undergoing bortezomib and lenalidomide is still progressing, the treatment response and duration of the early trial of daratumumab are satisfactory. Sundar Jagannath, director of the Multiple Myeloma Program at Mount Sinai School of Medicine in New York City, said, “This is the first time that myeloma has been found to respond to a monoclonal antibody treatment. In fact, because of refractory myeloma patients who have been exposed to chemotherapy. A therapeutic response to daratumumab prompted the FDA to award the daratumumab breakthrough therapy label."
Daratumumab was originally developed by Genmab and was subsequently licensed to Janssen (Johnson Johnson's subsidiary) for $1.1 billion. At the end of last year, 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). Earlier this year, Johnson & Johnson teamed up with the famous biopharmaceutical company Halozyme to develop a subcutaneous injection 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.
In the same year, Yang Sen submitted the BLA application to the FDA in early June; at the end of August, he published the latest research data of the new drug daratumumab developed by the company for the treatment of multiple myeloma. With this positive result, Johnson & Johnson and its partner Genmab received accelerated approval from the FDA. It takes 5 months to get it!
The so-called master loneliness:
Bristol-Myers Squibb and Aberdeen's other breakthrough multimyeloma drug elotuzumab are in clinical phase III. The drug is mainly aimed at the SLAMF7 antigen. The researchers believe that the drug not only kills tumor cells, but also activates the natural killer cells of the immune system and improves the immune system's ability to fight tumors. However, the clinical study stage showed that the efficacy of single drug was not as good as daratumumab.
In March of this year, pharmaceutical giant Celgene unexpectedly terminated the cooperation with German biopharmaceutical company MorphoSys in the development of CD38 monoclonal antibody MOR202 worth 800 million US dollars, I do not know that its Phase I clinical results scared off, or the strong man broke his wrist, afraid of catching Johnson Daratumumab?
Sanofi's anti-CD38 monoclonal antibody SAR650984 is still in clinical research, and there is still a period of time...
The "money" scene is optimistic:
In June of this year, daratumumab launched 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). Some people expect that once the drug is on the market, its market share will reach billions of dollars.
It can be seen that Johnson & Johnson is ready to let this medicine bloom in many places. In addition, due to the synergy between monoclonal antibodies and chemotherapy, daratumumab may not be used alone in the future, but in combination with chemotherapy. "In vitro studies have shown that if we use daratumumab and lenalidomide in combination, the killing effect on myeloma cells is enormous," the researchers explained. In any case, "daratumumab is a new class of drugs for myeloma patients who have failed to treat other diseases and are about to be knocked down by the disease. This is undoubtedly good news for the treatment of myeloma."
Source: Yaodu
Basket Stretcher,Basket Type Stretcher,Rescue Basket Stretcher,Emergency Basket Stretcher
jiangyin chenyi medical technology co.,ltd , https://www.chenyimed.com