Loncastuximab tesirine
Also known as Zynlonta, Loncastuximab tesirine-lpyl
ADC Therapeutics SA ADCT · Refractory Diffuse Large B-Cell Lymphoma; Relapsed Diffuse Large B-Cell Lymphoma
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
1
From ClinicalTrials.gov
Latest FDA action
Approved
BLA761196,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ADC Therapeutics SA ADCT Source: Company record for ADC Therapeutics SA (opens in a new tab)
- Indications
- Refractory Diffuse Large B-Cell Lymphoma; Relapsed Diffuse Large B-Cell Lymphoma Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- BLA 761196 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761196 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 16 Sep 20201 linked trial
- Filed Completed
- Approved Current stageFirst approval 23 Apr 2021
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Loncastuximab tesirine. Editors add each one with its source.
Filed application
No filed application is on record for Loncastuximab tesirine. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Loncastuximab tesirine.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT04384484ClinicalTrials.gov record for NCT04384484 (opens in a new tab)LOTIS 5 | Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma | Phase 3 | Active, not recruiting | 440 (actual) | 31 Mar 2026 (actual) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| BLA761196Action letter for BLA761196 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
AuthorisedConditional
Zynlonta (EMEA/H/C/005685)
- Authorised
- Therapeutic area
- Lymphoma, Large B-Cell, Diffuse;Lymphoma, B-Cell
- Marketing authorisation holder
- Swedish Orphan Biovitrum AB
- Active substance (INN)
- loncastuximab tesirine
- ATC code
- L01FX22
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Zynlonta (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 761196 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT04384484 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA BLA761196 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.