Amivantamab
As of the edition of 20 October 2026, Amivantamab is an antibody: marketed, first approved in 2021 (US); acts on EGFR and MET; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Antibody
- Brand name
- Rybrevant
- First approved
- 21 May 2021 (US)
- Approvals on record
- 16 in 4 regions
- Holder of the most recent approval
- Johnson & Johnson; 4 holders in all
- Registered trials
- 46, 3 stopped early
- Disease areas
- Cancer; Lungs and airways; Digestive system; Hormones; Inherited and neonatal; Mouth and teeth
US protection
US protection ends in 2033.
US protection ends in 2033, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Johnson & Johnson. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Amivantamab.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 6 | 0 | 5 | 1 |
| Phase 2 | 32 | 3 | 26 | 2 |
| Phase 3 | 7 | 0 | 7 | 0 |
| All trials | 46 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant and Lead sponsor of trials | 2021 to now |