Typical mAbs target one epitope. 1 FDA approved the first mAb, Orthoclone, in 1986 to help prevent rejection in organ transplantation. 2 The agency has now approved well over 100 novel mAbs 3...

2024年3月6日 · We focus on bsAbs that are approved or in clinical development, including bsAb-mediated dual modulators of signalling pathways, tumour-targeted receptor agonists, bsAb–drug conjugates,...

2022年3月9日 · Bispecific antibodies (BsAbs) are antibodies with two binding sites, directed against two different antigens or two different epitopes on the same antigen. BsAbs are clinically superior to monoclonal antibodies (MoAbs) and have a wide range of applications in tumor immunotherapy as well as in the treatment of other diseases such as hemophilia A ...

The Antibody Society maintains a comprehensive list of approved antibody therapeutics and those in regulatory review in the European Union (EU) or United States (US). In the table below, product candidates undergoing review are listed first, and approved products are listed in reverse chronological order by year of first approval.

2024年8月6日 · As of today, 12 bispecific antibodies (bsAbs) have received FDA approval, marking significant milestones in the advancement of targeted therapies for complex diseases such as cancer and autoimmune disorders. These approved bispecific antibodies are reshaping treatment landscapes by offering more precise and effective solutions.

On August 9, 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval of TALVEY™ (talquetamab-tgvs), a first-in-class bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma (r/r MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an ...

2022年9月6日 · The approved antibody therapies include 115 canonical antibodies, 14 antibody-drug conjugates, 7 bispecific antibodies, 8 antibody fragments, 3 radiolabeled antibodies, 1 antibody-conjugate immunotoxin, 2 immunoconjugates and 12 Fc-Fusion proteins.

2024年5月31日 · Following the approval of blinatumomab in 2014 for use in patients with relapsed and/or refractory B cell acute lymphoblastic leukaemia, a further ten bispecific antibodies have been approved...

In the rapidly advancing field of immuno-oncology, T-cell redirecting bispecific antibodies—engineered to simultaneously bind 2 different antigens—are an innovative and emerging platform in cancer immunotherapy.¹ The application of bispecific antibodies may soon expand beyond hematologic malignancies to treat solid tumors, including small cell l...

In 2021, amivantamab (Rybrevant; Janssen), an EGFR×c-MET bsAb, was granted accelerated and conditional approval in the United States and Europe for previously treated metastatic non-small-cell lung...