Prescription medicine
Amivantamab Brand names: Rybrevant
Amivantamab (Rybrevant) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the amivantamab FDA label on DailyMed (effective November 11, 2025); every amivantamab label on DailyMed.
Highlights of the record
FDA label of November 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageRYBREVANT 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.
Forms and strengths
- 350 mg
Injection.
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
- 3,268 through July 30, 2026
What is amivantamab used for?
From the label: indications and usageRYBREVANT 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. ( 1 , 2.2 ) in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. […]
Conditions named in the indications of amivantamab's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Rybrevant), Janssen Biotech, Inc., effective November 11, 2025 (SPL set 1466c070-9f97-4fa4-a955-6a6b59981fb8), via openFDA; the full label on DailyMed
What does the patient leaflet for amivantamab 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 RYBREVANT?RYBREVANT can cause skin reactions. You should limit your time in the sun during and for 2 months after your treatment with RYBREVANT. Wear protective clothing and use broad-spectrum UVA/UVB sunscreen during treatment with RYBREVANT.
Source: FDA drug label (Rybrevant), Janssen Biotech, Inc., effective November 11, 2025 (SPL set 1466c070-9f97-4fa4-a955-6a6b59981fb8), via openFDA; the full label on DailyMed
Is there a generic for amivantamab (Rybrevant)?
No generic amivantamab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the amivantamab label say about other medicines?
The amivantamab label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name amivantamab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carboplatin | warnings and precautions | RYBREVANT with Carboplatin and Pemetrexed Based on the pooled safety population [see Adverse Reactions (6.1) ], ocular toxicity occurred in 16% of patients treated with RYBREVANT in combination with carboplatin and pemetrexed. |
| Lazertinib | warnings and precautions | Monitor for signs and symptoms of VTE and treat as medically appropriate. Withhold RYBREVANT and lazertinib based on severity. |
| Pemetrexed | warnings and precautions | Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT and 3.1% discontinued pemetrexed. |
Source: FDA drug label (Rybrevant), Janssen Biotech, Inc., effective November 11, 2025 (SPL set 1466c070-9f97-4fa4-a955-6a6b59981fb8), via openFDA; the full label on DailyMed
What do FAERS reports show for amivantamab?
The FDA Adverse Event Reporting System holds 3,268 reports that list amivantamab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 246 are coded as a death and 658 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. Reports rose sharply in 2025 (1,482, against a median of 0 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
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 amivantamab?
16 other medicines are given the same way (intravenous) and in the same FDA class as amivantamab or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 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 |
|---|---|---|---|---|
| Pemetrexed | Lung cancer | 15 labelers | n/a | A presentation being discontinued |
| Etoposide | Lung cancer | 5 labelers | n/a | No current entry |
| Topotecan | Lung cancer | 4 labelers | n/a | No current entry |
| Nivolumab | Lung cancer | none listed | n/a | No current entry |
| Atezolizumab | Lung cancer | none listed | n/a | No current entry |
| Durvalumab | Lung cancer | none listed | n/a | No current entry |
| Ipilimumab | Lung cancer | none listed | n/a | No current entry |
| Ramucirumab | Lung cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as amivantamab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to amivantamab
- 16 medicines for the same use
- Amivantamab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other