RYBREVANT (amivantamab-vmjw) · Johnson & Johnson
RYBREVANT (amivantamab-vmjw) is a bispecific antibody indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring specific EGFR mutations. It is used as a first-line treatment in combination with lazertinib for patients with EGFR exon 19 deletions or exon 21 L858R mutations, and in combination with chemotherapy for those who have progressed after previous tyrosine kinase inhibitor therapy. Additionally, the drug is approved for patients with EGFR exon 20 insertion mutations, either as a first-line combination therapy with chemotherapy or as a single agent following platinum-based chemotherapy.
How RYBREVANT Works
Amivantamab-vmjw is a bispecific antibody that simultaneously binds to the extracellular domains of the epidermal growth factor receptor (EGFR) and the MET receptor. By binding to these targets, the drug disrupts tumor signaling by blocking ligand binding and promoting the degradation of the receptors. Furthermore, the presence of the antibody on the surface of tumor cells recruits immune effector cells, such as natural killer cells and macrophages, to destroy the cancer cells through antibody-dependent cellular cytotoxicity and trogocytosis.
Details
- Status
- Prescription
- First Approved
- 2021-05-21
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
RYBREVANT Approval History
What RYBREVANT Treats
4 indicationsRYBREVANT is approved for 4 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- First-line treatment of locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R substitution mutations (in combination with lazertinib)
- Locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R substitution mutations that has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (in combination with carboplatin and pemetrexed)
- First-line treatment of locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations (in combination with carboplatin and pemetrexed)
- Locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations that has progressed on or after platinum-based chemotherapy (as a single agent)
RYBREVANT Target & Pathway
ProTarget
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
RYBREVANT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in RYBREVANT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications RYBREVANT treats. First-in-class if their pivotal trials read out positive.
Johnson & Johnson's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RYBREVANT FDA Label Details
Indications & Usage
FDA Label (PDF)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. 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 prog...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.