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Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
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Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Related Experiment Video

Updated: Aug 22, 2025

Dynamic Imaging of Chimeric Antigen Receptor T Cells with [18F]Tetrafluoroborate Positron Emission Tomography/Computed Tomography
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Teclistamab: First Approval.

Connie Kang1

  • 1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. dru@adis.com.

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|November 9, 2022
PubMed
Summary

Teclistamab, a bispecific antibody targeting CD3 and BCMA, offers a new treatment for relapsed or refractory multiple myeloma. It has gained conditional EU and full US approval for patients with advanced disease.

Area of Science:

  • Oncology
  • Immunotherapy
  • Drug Development

Background:

  • Multiple myeloma is a hematologic malignancy with unmet needs in relapsed/refractory settings.
  • Existing therapies for relapsed/refractory multiple myeloma include immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies.
  • Bispecific antibodies represent a novel therapeutic approach in multiple myeloma treatment.

Purpose of the Study:

  • To summarize the key development milestones of teclistamab.
  • To highlight the regulatory approvals of teclistamab for relapsed or refractory multiple myeloma.
  • To provide an overview of teclistamab's journey to market.

Main Methods:

  • Review of preclinical and clinical development data for teclistamab.
  • Analysis of regulatory submission and approval processes in the EU and US.

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  • Summary of pivotal trial data supporting efficacy and safety.

    • Main Results:

    • Teclistamab, a bispecific antibody targeting CD3 and B cell maturation antigen (BCMA), has been developed.
    • Conditional approval was granted in the EU for patients with at least three prior therapies.
    • Full approval was obtained in the US for patients with at least four prior therapies.

    Conclusions:

    • Teclistamab represents a significant advancement in the treatment of relapsed or refractory multiple myeloma.
    • The drug's approval marks a milestone in bispecific antibody therapy for hematologic malignancies.
    • Further research may explore teclistamab in earlier lines of therapy or in combination regimens.