Quick answers
- What is Mosunetuzumab used for?
- The FDA-approved label (Lunsumio, Genentech, Inc., June 29, 2026) says: “LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Mosunetuzumab have a boxed warning?
- Yes. The FDA label for Lunsumio has a boxed warning (“WARNING: CYTOKINE RELEASE SYNDROME”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Mosunetuzumab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Mosunetuzumab been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Mosunetuzumab?
- 1 company lists prescription products of Mosunetuzumab in the FDA NDC Directory, including Genentech, Inc..
What Mosunetuzumab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). …
— FDA label: Lunsumio, Genentech, Inc., effective June 29, 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.
This label has a boxed warning. Its heading: WARNING: CYTOKINE RELEASE SYNDROME
. Read it on the full label →
2 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Concentrate · Injection |
|---|---|
| Route | Intravenous · Subcutaneous |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Lunsumio, Lunsumio Velo |
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.
- Genentech, Inc.4 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761263 LUNSUMIO, LUNSUMIO VELO | Genentech Inc | December 22, 2022 | 3, latest June 18, 2026 2026: Labeling · 2025: Efficacy · 2024: Efficacy |
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lunsumio, Genentech, Inc., effective June 29, 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 →