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T cells are a type of cell that helps the immune system fight cancer and infections. [3] Lifileucel is the first tumor-derived T cell immunotherapy approved by the US Food and Drug Administration (FDA). [3] It was approved for medical use in the United States in February 2024. [2] [4]
Afamitresgene autoleucel is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved ...
Mavorixafor improved absolute neutrophil counts and absolute lymphocyte counts, assessed over a 24-hour period four times throughout the study. [2] Absolute neutrophil counts below 500 cells/μL and absolute lymphocyte counts below 1000 cells/μL are associated with an increased risk of infections. [ 2 ]
BiTE: bi-specific T-cell engager; This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody ...
CTLA-4: short for Cytotoxic T-Lymphocyte-Associated protein 4 and also called CD152, is the target of Bristol-Myers Squibb's melanoma drug Yervoy, which gained FDA approval in March 2011. Expression of CTLA-4 on Treg cells serves to control T cell proliferation. [37] [38]
The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards. As of the end of 2013, the FDA and its predecessors had approved 1,452 drugs, though not all are still available, and some have been withdrawn for safety reasons. [5]
Teplizumab, sold under the brand name Tzield, is a humanized anti-CD3 monoclonal antibody that is the first approved treatment indicated to delay the onset of stage 3 type 1 diabetes in people with stage 2 type 1 diabetes. [3] [4] [5] The Fc region of this antibody has been engineered to have Fc receptor non-binding (FNB) properties. [6]
It is a bispecific T-cell engager that binds delta-like ligand 3 and CD3. [17] The most common adverse reactions include cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, and constipation, anemia and nausea. [18] Tarlatamab was approved for medical use in the United States in May 2024. [18] [19]