Teclistamab

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Teclistamab
Monoclonal antibody
TypeBi-specific T-cell engager
SourceHumanized
TargetBCMA, CD3
Names
Other namesJNJ-64007957, teclistamab-cqyv
Clinical data
Drug classAntineoplastic
Main usesMultiple myeloma[1]
Side effectsFever, cytokine release syndrome, muscle pain, tiredness, upper respiratory tract infection, pneumonia, diarrhea, low white blood cells, low red blood cells, low platelets[2]
Routes of
use		Intravenous
External links
AHFS/Drugs.comMonograph
Legal
License data
Legal status
Chemical and physical data
FormulaC6383H9847N1695O2003S40
Molar mass143662.25 g·mol−1

Teclistamab, sold under the brand name Tecvayli, is a medication used to treat multiple myeloma.[1] It is used when other treatments have failed.[1] It is given by injection under the skin.[2]

Common side effects include fever, cytokine release syndrome, muscle pain, tiredness, upper respiratory tract infection, pneumonia, diarrhea, low white blood cells, low red blood cells, and low platelets.[2] Other side effects may include liver problems, infection, and allergic reactions.[2] Use in pregnancy may harm the baby.[2] It is amonoclonal antibody that simultaneously attaches to the CD3 receptors on T-cells and the B-cell maturation antigen (BCMA) myeloma cells.[1]

Teclistamab was approved for medical use in Europe and United States in 2022.[1][2] In the United States it costs about 40,000 USD per month as of 2022.[4] It is not approved in the United Kingdom as of 2022.[4]

Medical uses

Teclistamab is indicated for the treatment of adults with relapsed and refractory multiple myeloma.[2][1] It is used in those who have received at least three prior treatments, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.[1]

Dosage

The dose is based on a person weight.[1] It is given on day 1, 3, and 5 and than is given weekly.[1]

Side effects

The most common side effects (≥20%) occurring in the 165 people in the safety population, were fever, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea.[5] The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.[5]

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).[5] Among people who received teclistamab at the recommended dose, CRS occurred in 72%, neurologic toxicity in 57%, and ICANS in 6%.[5] Grade 3 CRS occurred in 0.6% of people and Grade 3 or 4 neurologic toxicity occurred in 2.4%.[5]

History

Teclistamab-cqyv was evaluated in MajesTEC-1 (NCT03145181; NCT04557098), a single-arm, multi-cohort, open-label, multi-center study.[5] 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.[5]

The application for teclistamab was granted orphan drug, priority review, and breakthrough therapy designations.[5] Teclistamab is the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager.[5]

Society and culture

Legal status

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.[1][6] Tecvayli was reviewed under EMA's accelerated assessment program.[1] The applicant for this medicinal product is Janssen-Cilag International N.V.[1] Teclistamab was approved for medical use in the European Union in August 2022.[1]

Names

Teclistamab is the international nonproprietary name (INN).[7]

References

  1. ↑ 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 1.11 1.12 1.13 "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.
  2. ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 "Tecvayli- teclistamab injection". DailyMed. 31 October 2022. Archived from the original on 18 November 2022. Retrieved 18 November 2022.
  3. ↑ "Drug Approval Package: Tecvayli". U.S. Food and Drug Administration (FDA). 23 November 2022. Archived from the original on 4 December 2022. Retrieved 4 December 2022.
  4. ↑ 4.0 4.1 "Teclistamab". SPS - Specialist Pharmacy Service. 24 September 2021. Archived from the original on 2 December 2021. Retrieved 16 December 2022.
  5. ↑ 5.0 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 "FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma". U.S. Food and Drug Administration (FDA). 25 October 2022. Archived from the original on 27 October 2022. Retrieved 28 October 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  6. ↑ "Janssen Receives Positive CHMP Opinion for Novel Bispecific Antibody Tecvayli (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma (RRMM)". Janssen (Press release). 22 July 2022. Archived from the original on 30 July 2022. Retrieved 30 July 2022.
  7. ↑ World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information. 33 (3). hdl:10665/330879.

External links

External sites:
Identifiers:
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