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Rybrevant

amivantamab-vmjw
Bispecific EGFR-MET Antibody FDA Approved 2021 Janssen
Route
IV
Half-Life
11.8 days
FDA Approved
2021
Manufacturer
Janssen
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1. Indications and Usage

NSCLC: EGFR exon 20 insertion-mutated NSCLC. Also combination regimens.

2. Dosage and Administration

<80 kg: 1050 mg IV; ≥80 kg: 1400 mg IV. Weekly ×4, then Q2W.

3. Dosage Forms and Strengths

Injection: 350 mg/7 mL vial

4. Contraindications

None listed.

5. Warnings and Precautions
  • Infusion Reactions: 66%. Premedicate.
  • Dermatologic Reactions: Rash 74%.
  • Ocular Toxicity: Keratitis reported.
  • ILD/Pneumonitis: Fatal outcomes.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Rash (74%), Infusion Reactions (66%), Paronychia (45%), Fatigue (33%), Musculoskeletal Pain (28%), Edema (28%), Nausea (25%), Dyspnea (21%)

Rash
74%
Infusion Reactions
66%
Paronychia
45%
Fatigue
33%
Musculoskeletal Pain
28%
Edema
28%
Nausea
25%
Dyspnea
21%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Not expected to interact via CYP enzymes.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Bispecific antibody targeting EGFR and MET, blocking ligand binding and mediating ADCC.

Pharmacokinetics

t½: ~11.3 days. Vd: 5.1 L.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Rybrevant Trials on ClinicalTrials.gov ↗ 📚 PubMed: Rybrevant Clinical Trials ↗
FDA-Approved Tumor Types

Rybrevant has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Non-Small Cell Lung Cancer
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Rybrevant. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Rybrevant (amivantamab-vmjw) approved for?

Rybrevant (amivantamab-vmjw) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Rybrevant (amivantamab-vmjw) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Rybrevant (amivantamab-vmjw) work?

Bispecific antibody targeting EGFR and MET, blocking ligand binding and mediating ADCC.

What are the most common side effects?

Rash (74%), Infusion Reactions (66%), Paronychia (45%), Fatigue (33%), Musculoskeletal Pain (28%), Edema (28%), Nausea (25%), Dyspnea (21%) Rash 74% Infusion Reactions 66% Paronychia 45% Fatigue 33% Musculoskeletal Pain 28% Edema 28% Nausea 25% Dyspnea 21%

← All Therapies Full Prescribing Information ↗