Loncastuximab tesirine
Humanized | |
Target | CD19 |
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Clinical data | |
Pronunciation | /ˌlɒnkæsˈtʌksɪmæb.ˈtɛsɪriːn/ LON-kas-TUK-si-mab TE-si-reen |
Trade names | Zynlonta |
Other names | ADCT-402, loncastuximab tesirine-lpyl |
AHFS/Drugs.com | Monograph |
MedlinePlus | a621031 |
License data | |
Intravenous | |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
DrugBank | |
ChemSpider |
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UNII | |
KEGG | |
Chemical and physical data | |
Formula | C6544H10048N1718O2064S52 |
Molar mass | 147481.45 g·mol−1 |
Loncastuximab tesirine, sold under the brand name Zynlonta, is a
The most common side effects include increased levels of
Loncastuximab tesirine was approved for medical use in the United States in April 2021,[1][3][4] and in the European Union in December 2022.[2] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[5]
Medical uses
Loncastuximab tesirine is indicated for the treatment of adults with relapsed or refractory large B-cell lymphoma and high-grade B-cell lymphoma.[1][2]
Technology
The humanized
History
The benefit and side effects of loncastuximab tesirine were evaluated in one clinical trial, ADCT-402-201 (LOTIS-2 / NCT03589469), that included 145 participants with relapsed or refractory diffuse large B-cell lymphoma after at least two prior treatments that did not work or were no longer working.[1][4] Participants received loncastuximab tesirine 0.15 mg/kg every 3 weeks for 2 treatment cycles, then 0.075 mg/kg every 3 weeks for subsequent treatment cycles.[4] Loncastuximab tesirine treatment was continued until either disease worsened or participants experienced unacceptable side effects (toxicity).[4] The benefit of loncastuximab tesirine was evaluated by measuring how many participants had complete or partial tumor shrinkage (response) and by how long that response lasted.[4] Participants in the clinical trial were also evaluated for side effects for the purpose of this drug application.[4] Trials were conducted at 28 sites in the United States, the United Kingdom, Italy, and Switzerland.[4]
Loncastuximab tesirine was granted orphan drug designation by the FDA for the treatment of diffuse large B-cell lymphoma.[8][5] Loncastuximab tesirine was approved under FDA's accelerated approval program.[4]
Society and culture
Legal status
On 15 September 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 marketing authorization for the medicinal product Zynlonta, intended for the treatment of adults with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).[9] The applicant for this medicinal product is ADC Therapeutics (NL) B.V.[9] Loncastuximab tesirine was approved for medical use in the European Union in December 2022.[2][10]
Research
Given its mechanism of action, loncastuximab tesirine may be appealing in patients ineligible for CAR-T cell therapy.[11]
References
- ^ a b c d e f "Zynlonta- loncastuximab tesirine injection, powder, lyophilized, for solution". DailyMed. Archived from the original on 2 June 2021. Retrieved 1 June 2021.
- ^ a b c d e f "Zynlonta EPAR". European Medicines Agency (EMA). 14 September 2022. Archived from the original on 27 January 2023. Retrieved 26 January 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Drug Approval Package: Zynlonta". U.S. Food and Drug Administration (FDA). 24 May 2021. Archived from the original on 2 June 2021. Retrieved 1 June 2021.
- ^ a b c d e f g h "Drug Trials Snapshots: Zynlonta". U.S. Food and Drug Administration. 23 April 2021. Archived from the original on 28 July 2023. Retrieved 9 September 2023. This article incorporates text from this source, which is in the public domain.
- ^ a b Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain.
- PMID 23210908.
- ^ "Pyrrolobenzodiazepine". ADC Review. Archived from the original on 2 August 2017. Retrieved 2 August 2017.
- ^ "Loncastuximab tesirine Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 8 June 2017. Archived from the original on 2 June 2021. Retrieved 1 June 2021.
- ^ a b "Zynlonta : Pending EC decision". European Medicines Agency (EMA). 15 September 2022. Archived from the original on 16 September 2022. Retrieved 18 September 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Zynlonta Product information". Union Register of medicinal products. Archived from the original on 10 January 2023. Retrieved 3 March 2023.
- S2CID 247010986.
External links
- "Loncastuximab tesirine-lpyl". NCI Drug Dictionary. National Cancer Institute.
- "Loncastuximab tesirine-lpyl". National Cancer Institute. 21 May 2021.
- Clinical trial number NCT03589469 for "Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (LOTIS-2)" at ClinicalTrials.gov