Difference between revisions of "Teclistamab (Tecvayli)"

Revision as of 11:31, 8 November 2022

General information

Class/mechanism from the NCI Drug Dictionary: A bispecific humanized monoclonal antibody against human CD3, a T-cell surface antigen, and human B-cell maturation antigen (BCMA; TNFRSF17), a tumor-associated antigen (TAA) expressed on plasma cells, with potential antineoplastic activity. Upon administration, teclistamab binds to both CD3 on T cells and BCMA expressed on malignant plasma cells. This results in the cross-linking of T cells and tumor cells, and induces a potent cytotoxic T-lymphocyte (CTL) response against BCMA-expressing plasma cells.
Route: IV
Extravasation: no information

Diseases for which it is established

Multiple myeloma

History of changes in FDA indication

10/25/2022: Approved for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. (Based on MajesTEC-1)

Also known as

Code name: JNJ 64007957
Generic name: teclistamab-cqyv
Brand name: Tecvayli

References

@@ Line 5: / Line 5: @@
 ==Diseases for which it is established==
-===[[Multiple myeloma]]===
+*[[Multiple myeloma]]
-#'''MajesTEC-1 Phase 1:''' Usmani SZ, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Rosinol L, Chari A, Bhutani M, Karlin L, Benboubker L, Pei L, Verona R, Girgis S, Stephenson T, Elsayed Y, Infante J, Goldberg JD, Banerjee A, Mateos MV, Krishnan A. Teclistamab, a B-cell maturation antigen × CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study. Lancet. 2021 Aug 21;398(10301):665-674. Epub 2021 Aug 10. [https://doi.org/10.1016/s0140-6736(21)01338-6 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34388396/ PubMed] NCT03145181
-##'''Update:''' Moreau P, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Nooka AK, Martin T, Rosinol L, Chari A, Karlin L, Benboubker L, Mateos MV, Bahlis N, Popat R, Besemer B, Martínez-López J, Sidana S, Delforge M, Pei L, Trancucci D, Verona R, Girgis S, Lin SXW, Olyslager Y, Jaffe M, Uhlar C, Stephenson T, Van Rampelbergh R, Banerjee A, Goldberg JD, Kobos R, Krishnan A, Usmani SZ. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022 Aug 11;387(6):495-505. Epub 2022 Jun 5. [https://doi.org/10.1056/nejmoa2203478 link to original article] [https://pubmed.ncbi.nlm.nih.gov/35661166/ PubMed]
-#'''MajesTEC-1 Phase 2:''' Moreau P, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Nooka AK, Martin T, Rosinol L, Chari A, Karlin L, Benboubker L, Mateos MV, Bahlis N, Popat R, Besemer B, Martínez-López J, Sidana S, Delforge M, Pei L, Trancucci D, Verona R, Girgis S, Lin SXW, Olyslager Y, Jaffe M, Uhlar C, Stephenson T, Van Rampelbergh R, Banerjee A, Goldberg JD, Kobos R, Krishnan A, Usmani SZ. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022 Aug 11;387(6):495-505. Epub 2022 Jun 5. [https://doi.org/10.1056/nejmoa2203478 link to original article] [https://pubmed.ncbi.nlm.nih.gov/35661166/ PubMed] NCT04557098
 ==History of changes in FDA indication==