RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) · Johnson & Johnson
RYBREVANT FASPRO is a combination of amivantamab, a bispecific antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The therapy is used for patients with specific epidermal growth factor receptor (EGFR) mutations, including exon 19 deletions, exon 21 L858R substitutions, or exon 20 insertions. Depending on the clinical setting and mutation type, it is administered as a single agent or in combination with other therapies such as lazertinib, carboplatin, or pemetrexed.
How RYBREVANT FASPRO Works
Amivantamab is a bispecific antibody that binds to the extracellular domains of EGFR and MET to disrupt signaling and induce receptor degradation. By binding to these receptors on the surface of tumor cells, it also targets them for destruction by immune effector cells through antibody-dependent cellular cytotoxicity and trogocytosis. The hyaluronidase component acts as an endoglycosidase that transiently depolymerizes hyaluronan in the subcutaneous tissue. This increases tissue permeability to facilitate the local delivery and absorption of the treatment.
Details
- Status
- Prescription
- First Approved
- 2025-12-17
- Routes
- SINGLE-USE
- Dosage Forms
- VIAL, INJECTION
RYBREVANT FASPRO Approval History
What RYBREVANT FASPRO Treats
1 indicationsRYBREVANT FASPRO is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
RYBREVANT FASPRO 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 FASPRO 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 FASPRO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications RYBREVANT FASPRO treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 FASPRO FDA Label Details
Indications & Usage
FDA Label (PDF)RYBREVANT FASPRO is a combination of amivantamab, a bispecific EGF receptor-directed and MET receptor-directed antibody, and hyaluronidase, an endoglycosidase indicated: in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with 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 dise...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.