RYBREVANT FASPROI
RYBREVANT FASPRO is a combination of amivantamab, a bispecific antibody, and hyaluronidase, an endoglycosidase. It is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring specific EGFR mutations, including exon 19 deletions, exon 21 L858R substitutions, or exon 20 insertions. The therapy is used as a single agent or in combination with other treatments, such as lazertinib or chemotherapy, depending on the patient's specific mutation profile and prior treatment history.
How RYBREVANT FASPROI Works
Amivantamab is a bispecific antibody that binds to the extracellular domains of EGFR and MET, disrupting tumor signaling and inducing receptor degradation. It also targets tumor cells for destruction by immune effector cells, such as natural killer cells and macrophages, through antibody-dependent cellular cytotoxicity and trogocytosis. The hyaluronidase component increases the permeability of subcutaneous tissue by temporarily depolymerizing hyaluronan. This effect is local and reversible, with tissue permeability typically restored within 24 to 48 hours.
Details
- Status
- Prescription
- First Approved
- 2026-02-13
- Routes
- SINGLE-USE
- Dosage Forms
- VIAL
RYBREVANT FASPROI Approval History
What RYBREVANT FASPROI Treats
1 indicationsRYBREVANT FASPROI is approved for 1 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
RYBREVANT FASPROI 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 FASPROI Competitors
Pro10 other drugs also target EGFR. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (EGFR). Earlier expiry dates signal biosimilar/generic opportunities.
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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 FASPROI FDA Label Details
ProIndications & 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.