Teclistamab: First Approval
Open accessAbstract
Teclistamab (TECVAYLI®), a bispecific antibody that targets CD3 and B cell maturation antigen (BCMA), is being developed by Janssen Research and Development for the treatment of relapsed or refractory multiple myeloma. Teclistamab was recently granted conditional approval in the EU for the treatment of adult patients with relapsed and refractory multiple myeloma who have received three or more prior therapies (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody) and have demonstrated disease progression on the last therapy. Teclistamab was subsequently approved in the US for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody). This article summarizes the milestones in the development of teclistamab leading to this first approval for relapsed or refractory multiple myeloma.
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Teclistamab has received approval from the EMA and FDA for the treatment of relapsed/refractory multiple myeloma patients who have received at least three prior lines of therapy.
“Teclistamab, a BCMA/CD3-targeted bsAb, has received approval from both the EMA and FDA for the treatment of patients with RRMM who have received at least three prior lines of therapy in 2022 [203].”
From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [203]
The Introduction reports EU approval in August 2022 after three or more prior therapies and US approval in October 2022 after at least four prior lines of therapy. The claim correctly identifies approvals in both jurisdictions in 2022, but incorrectly applies the three-prior-line threshold to the US approval. (LLM, conf=0.92)
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- [8]Ligand Pharmaceuticals. Ligand announces licensing partner Janssen has filed an IND for an antibody discovered using the OmniAb® technology [media release]. 28 Mar 2017. https://investor.ligand.com/press-releases.
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- Authors
- Kang, C.
- Affiliations
- Springer Nature (New Zealand) (NZ)
- Corresponding author
- Kang, Connie
- Venue
- Drugs
- Published
- 2022-11
- Volume
- 82
- Issue
- 16
- Pages
- 1613-1619
- ISSN
- 0012-6667 (ISSN-L)
- 1179-1950
- PMC
- PMC9646474
- OpenAlex
- W4308684844
- Semantic Scholar
- 5b3c64c7c798c2209ae914ec86bdaadd2aa3b4b0
- Cited by
- 92
- References
- 13
- Citations by year
- 2026: 16 · 2025: 17 · 2024: 41 · 2023: 18
- FWCI
- 13.86
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Drugs (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Figshare (submittedVersion, cc-by-nc)
- Figshare
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein Degradation and Inhibitors
- Keywords
- teclistamab, bispecific antibodies, CD3, BCMA, relapsed/refractory multiple myeloma, drug approval, conditional approval, drug development milestones, anti-CD38 monoclonal antibody, proteasome inhibitors, immunomodulators
- MeSH terms
- Adult, Antineoplastic Agents, Antiviral Agents, Humans, Multiple Myeloma, Antibodies, Bispecific, Molecular Targeted Therapy, Proteasome Inhibitors
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