Prescription medicine
Loncastuximab tesirine Brand names: Zynlonta
Loncastuximab tesirine (Zynlonta) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the loncastuximab tesirine FDA label on DailyMed (effective June 12, 2026); every loncastuximab tesirine label on DailyMed.
Highlights of the record
FDA label of June 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.
Forms and strengths
- 10 mg/2ml
Injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 393 through July 30, 2026
What is loncastuximab tesirine used for?
From the label: indications and usageZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). […]
Conditions named in the indications of loncastuximab tesirine's FDA labels, with every medicine labeled for each:
Source: FDA drug label (ZYNLONTA), ADC Therapeutics America, Inc., effective June 12, 2026 (SPL set af54af12-3edf-4301-8bc5-0446bc813c1d), via openFDA; the full label on DailyMed
What does the patient leaflet for loncastuximab tesirine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while receiving ZYNLONTA?Avoid or limit your exposure to sunlight, including sunlight through glass, such as buildings or vehicle windows and artificial sunlight such as sunlamps or tanning beds. Exposure to sunlight during treatment with ZYNLONTA can cause skin reaction or rash. Use sun protection measures such as sunscreen and wear loose-fitting clothes that cover your skin while out in sunlight.
Source: FDA drug label (ZYNLONTA), ADC Therapeutics America, Inc., effective June 12, 2026 (SPL set af54af12-3edf-4301-8bc5-0446bc813c1d), via openFDA; the full label on DailyMed
Is there a generic for loncastuximab tesirine (Zynlonta)?
No generic loncastuximab tesirine is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for loncastuximab tesirine?
The FDA Adverse Event Reporting System holds 393 reports that list loncastuximab tesirine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 135 are coded as a death and 104 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as loncastuximab tesirine?
36 other medicines are given the same way (intravenous) and in the same FDA class as loncastuximab tesirine or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
| Clofarabine | Leukemia, lymphoma and myeloma | 9 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Loncastuximab tesirine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other