Teclistamab, sold under the brand name Tecvayli, is a human
bispecific monoclonal antibody used for the treatment of relapsed and refractory
multiple myeloma.[8] It is a bispecific antibody that targets the
CD3 receptor expressed on the surface of
T-cells and
B-cell maturation antigen (
BCMA), which is expressed on the surface of
malignant multiple myeloma B-lineage cells.[8][9]
The most common side effects include
hypogammaglobulinemia (low immunoglobulin or antibody levels in the blood, which increases the risk of infection), cytokine release syndrome,
neutropenia (low levels of neutrophils, a type of white blood cell that fights infection),
anemia (low levels of red blood cells or hemoglobin), pain in the muscles and bones, tiredness,
thrombocytopenia (low levels of blood platelets, components that help the blood to clot),
injection site reactions, upper respiratory tract (nose and throat) infection,
lymphopenia (low levels of lymphocytes, a type of white blood cell),
diarrhea,
pneumonia (infection of the lungs), nausea (feeling sick), fever, headache, cough, constipation and pain.[8]
Teclistamab is
indicated for the treatment of adults with relapsed and refractory multiple myeloma.[6][8][17][18]
Contraindications
In the US, the prescribing information for teclistamab has a
boxed warning for life threatening or fatal
cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated
neurotoxicity (ICANS).[10] Among people who received teclistamab at the recommended dose, CRS occurred in 72%, neurologic toxicity in 57%, and ICANS in 6%.[10] Grade 3 CRS occurred in 0.6% of people and Grade 3 or 4 neurologic toxicity occurred in 2.4%.[10]
Adverse effects
The most common adverse reactions (≥20%) occurring in the 165 patients in the safety population, were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea.[10] The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.[10]
History
Teclistamab-cqyv was evaluated in MajesTEC-1 (NCT03145181; NCT04557098), a single-arm, multi-cohort, open-label, multi-center study.[10] The efficacy population consisted of 110 participants who had previously received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and had not received prior BCMA-targeted therapy.[10]
On 21 July 2022, the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Tecvayli, intended for treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies.[8][9] Tecvayli was reviewed under EMA's accelerated assessment program.[8] The applicant for this medicinal product is Janssen-Cilag International N.V.[8] Teclistamab was approved for medical use in the European Union in August 2022.[8][19]
^
abcdefghij"Tecvayli EPAR". European Medicines Agency. 18 July 2022.
Archived from the original on 10 December 2022. Retrieved 14 October 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^"Tecvayli Product information". Union Register of medicinal products. 12 December 2022.
Archived from the original on 3 March 2023. Retrieved 3 March 2023.
^World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information. 33 (3).
hdl:10665/330879.