Quick answers
- What is Elranatamab-bcmm used for?
- The FDA-approved label (Elrexfio, U.S. Pharmaceuticals, May 14, 2026) says: “ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Elranatamab-bcmm have a boxed warning?
- Yes. The FDA label for Elrexfio has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Elranatamab-bcmm?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Elranatamab-bcmm been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Elranatamab-bcmm?
- 2 companies list prescription products of Elranatamab-bcmm in the FDA NDC Directory, including Pfizer Laboratories Div Pfizer Inc and U.S. Pharmaceuticals.
What Elranatamab-bcmm is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response […]. …
— FDA label: Elrexfio, U.S. Pharmaceuticals, effective May 14, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Elrexfio |
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.
- Pfizer Laboratories Div Pfizer Inc2 products
- U.S. Pharmaceuticals1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761345 ELREXFIO | Pfizer Inc | August 14, 2023 | 6, latest March 25, 2026 2026: REMS · 2026: Labeling · 2025: 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
| RxCUI (RxNorm) | 2644885, 2644891 |
|---|---|
| SPL set ID of the quoted label | aa044060-5b4b-4692-bf0f-9a50e140b10e |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761345 |
| Active ingredients (FDA) | ELRANATAMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Elrexfio, U.S. Pharmaceuticals, effective May 14, 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 →