Quick answers
- What is Tafasitamab-cxix used for?
- The FDA-approved label (Monjuvi, Incyte Corporation, February 2, 2026) says: “MONJUVI, in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tafasitamab-cxix have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tafasitamab-cxix?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tafasitamab-cxix been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tafasitamab-cxix?
- 1 company lists prescription products of Tafasitamab-cxix in the FDA NDC Directory, including Incyte Corporation.
What Tafasitamab-cxix is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MONJUVI, in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate […]. …
— FDA label: Monjuvi, Incyte Corporation, effective February 2, 2026. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Monjuvi |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Incyte Corporation2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761163 MONJUVI | Morphosys Us Inc | July 31, 2020 | 2, latest June 18, 2025 2025: Efficacy · 2021: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2387338, 2387343 |
|---|---|
| SPL set ID of the quoted label | ec13ac6b-bfde-4e84-907a-83bd69584d95 |
| FDA labels (SPL) | 2 |
| FDA applications | BLA761163 |
| Active ingredients (FDA) | TAFASITAMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Monjuvi, Incyte Corporation, effective February 2, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →