The last few decades have witnessed an acceleration in the discovery and development of therapeutic antibodies. They have revolutionized modern medicine, offering targeted therapies with high specificity and fewer side effects.
From monospecific human antibodies like erenumab for migraines, to bispecific murine antibodies like blinatumomab for cancer, therapeutic antibodies are highly valuable in treating various therapeutic areas, especially cancer. The number of FDA approvals for antibody drugs are quickly growing year by year.
The steady increase in the number of FDA-approved therapeutic antibodies, especially for cancer, reflects the incredible advancements in antibody research and clinical trials. Antibodies are now highly diverse, with different formats such as VHH, scFv, and Fab antibodies, as well as different expression systems such as CHO cells, murine cells, and E. coli.
Cancer in particular is dominating the antibody therapeutics space, since monoclonal antibodies can directly target tumor cells while simultaneously promoting the induction of long-lasting anti-tumor immune responses.
In the past year alone, five therapeutic antibodies for cancer have been approved.
Retifanlimab: Approved in March, this monospecific antibody targets PD-1 and is used to treat metastatic or recurrent locally advanced Merkel cell carcinoma.
Epcoritamab: On May 19, this bispecific antibody was approved to treat relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma.
Glofitamab: Approved in June, this bispecific is also used to treat selected relapsed or refractory large B-cell lymphomas, but has a Fab-Fc x Fab-Fab-Fc format rather than a full-length format.
Talquetamab: On Aug 9, the FDA granted accelerated approval for relapsed or refractory multiple myeloma.
Elranatamab: The latest antibody cancer drug to be approved, this bispecific antibody also treats multiple myeloma by targeting the CD3 T-cell engager.
This report aims to explore the events and trends of the biopharmaceutical industry in Q2 (April, May, June). Besides crovalimab and Vyloy, two more novel antibody drugs have been approved this year
The start of 2024 has seen leaps in deals for antibody therapeutics, especially ADCs (antibody-drug conjugates). This report aims to explore the events and trends of the biopharmaceutical industry in Q1. As of now, only two novel antibody drugs have been approved this year, but many more in regulatory review are expected to be fully approved.
The approval of Eli Lilly’s Kisunla (donanemab-azbt), a humanized IgG1 monoclonal antibody, is just one of the major advancements in the treatment of Alzheimer's disease (AD)! This drug is now available in the US for adults with early symptomatic AD, including those with mild cognitive impairment (MCI) and mild dementia stage of AD with amyloid pathology.
Blood disorders, including anemias, coagulopathies, leukemias, lymphomas, and thrombocytopenias, disrupt the normal functioning of blood components. Antibody therapeutics, such as monoclonal antibodies (mAbs), have transformed treatment approaches by offering targeted, high-specificity interventions.