FDA Approved Bispecific Antibodies-KMD Bioscience

As of the last update in August 2024, bispecific antibodies have become an exciting and evolving area in immunotherapy, particularly in cancer treatment. These antibodies are designed to engage two different targets simultaneously, which can enhance their effectiveness compared to traditional monoclonal antibodies.

Here are some FDA-approved bispecific antibodies:

Blinatumomab (Blincyto):
This was one of the first bispecific antibodies approved by the FDA. It targets CD19 and CD3, which helps redirect T cells to attack B-cell malignancies, such as acute lymphoblastic leukemia (ALL).
Mechanism: Engages T cells by binding to CD3 and brings them into close proximity with CD19-expressing B cells, leading to B cell lysis.

DuoBody®-CD3xCD20 (Epkinly, also known as ABBV181):
This bispecific antibody targets both CD3 and CD20, with the aim of treating B-cell malignancies.

Catumaxomab (Removab):
This bispecific antibody targets EpCAM (epithelial cell adhesion molecule) and CD3. It was used for the treatment of malignant ascites, though its use has been somewhat limited.

Teprotumumab (Teprotumumab-trbw):
Targeting the insulin-like growth factor-1 receptor (IGF-1R), it's used for treating thyroid eye disease.

Mosunetuzumab (Lunsumio):
This bispecific antibody targets CD20 and CD3 and is used for the treatment of certain types of non-Hodgkin lymphoma.

Itepekimab (also known as ABBV181):
Targeting IL-13 and IL-4, it’s being investigated for various conditions related to inflammation and fibrosis.

Emicizumab (Hemlibra):
Target: Factor IXa/X
Indication: Hemophilia A
Mechanism: Mimics factor VIII by bridging activated factor IX and factor X, promoting blood coagulation in hemophilia A patients.

Amivantamab (Rybrevant):
Target: EGFR/c-MET
Indication: Non-small cell lung cancer (NSCLC)
Mechanism: Targets and inhibits EGFR and c-MET pathways, leading to reduced tumor cell proliferation and survival.

Teclistamab (Tecvayli):
Target: BCMA/CD3
Indication: Multiple myeloma
Mechanism: Connects BCMA on multiple myeloma cells with CD3 on T cells, activating T-cell-mediated cytotoxicity against the myeloma cells.

The field of bispecific antibodies is growing rapidly, with new candidates continually undergoing clinical trials and gaining approvals.
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