Quick answers
- What is Amivantamab-vmjw used for?
- The FDA-approved label (Rybrevant, Janssen Biotech, Inc., November 11, 2025) says: “RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated: in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Amivantamab-vmjw have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Amivantamab-vmjw?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Amivantamab-vmjw been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Amivantamab-vmjw?
- 1 company lists prescription products of Amivantamab-vmjw in the FDA NDC Directory, including Janssen Biotech, Inc..
What Amivantamab-vmjw is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated: in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. …
— FDA label: Rybrevant, Janssen Biotech, Inc., effective November 11, 2025. 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.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Rybrevant |
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.
- Janssen Biotech, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761210 RYBREVANT | Janssen Biotech | May 21, 2021 | 10, latest November 7, 2025 2025: Labeling · 2025: Labeling · 2025: 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) | 2549734, 2549739 |
|---|---|
| SPL set ID of the quoted label | 1466c070-9f97-4fa4-a955-6a6b59981fb8 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761210 |
| Active ingredients (FDA) | AMIVANTAMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Rybrevant, Janssen Biotech, Inc., effective November 11, 2025; 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 →