FDA approval · Drugs@FDA
RYBREVANT FASPROamivantamab and hyaluronidase-lpuj
BLA761484 ·
FDA approved the original biologics license application for RYBREVANT FASPRO on February 13, 2026, sponsored by JANSSEN BIOTECH. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- BLA761484
- Sponsor
- JANSSEN BIOTECH
- Original approval
- Review
- standard review
- Submission class
- Type 5 - New Formulation or New Manufacturer
- Active ingredient
- amivantamab and hyaluronidase-lpuj
Browse every approval whose brand starts with R, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| amivantamab and hyaluronidase-lpuj 2,400MG/30,000 UNITS PER 15ML | VIAL | SINGLE-USE | Prescription |
| amivantamab and hyaluronidase-lpuj 1,600MG/20,000 UNITS PER 10ML | VIAL | SINGLE-USE | Prescription |
| amivantamab and hyaluronidase-lpuj 3,5200MG/44,000 UNITS PER 22ML | VIAL | SINGLE-USE | Prescription |
| amivantamab and hyaluronidase-lpuj 2,240MG/28,000 UNITS PER 14ML | VIAL | SINGLE-USE | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
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