amivantamab-vmjw
Trade name: Rybrevant
mAbapprovedMulti-specificBreakthrough Therapy FDA
Approved
May 21, 2021
Clinical trial activity
44 trials · 27 clinical orgs · 1 marketing orgs
Phase 1
16
Phase 2
34
Phase 3
7
Phase 4
0
Earliest trial started May 24, 2016 (NCT02609776)
Timeline
2010s
- Jan 1, 2016
Johnson and Johnson — Earliest Phase 1 Sponsor(trial)
2020s
- Jan 1, 2020
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2020
Earliest Phase 3 Sponsor(trial)
- May 21, 2021
Johnson and Johnson — Earliest FDA Approval
- May 21, 2021
Johnson and Johnson — Marketing Organization
- May 21, 2021
Johnson and Johnson — NDA Secondary Org
- May 21, 2021
Johnson and Johnson — NDA Organization
Indications
Approved for
Studied for
- Anxiety · Phase 2
- Bacteremia · Phase 2
- Bacterial Infections · Phase 2
- Breast Neoplasms · Phase 1
- Carcinoma, Hepatocellular · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 3
- Carcinoma, Squamous Cell · Phase 2
- Colitis, Ulcerative · Phase 1
- Colorectal Neoplasms · Phase 3
- Depression · Phase 1
- Esophageal Neoplasms · Phase 2
- Gastrointestinal Microbiome · Phase 2
- Glioblastoma · Phase 1
- Glioma · Phase 1
- Head and Neck Neoplasms · Phase 1
- Lung Neoplasms · Phase 2
- Major Depressive Disorder · Phase 2
- Neoplasms · Phase 1
- Obesity · Early Phase 1
- Ovarian Neoplasms · Phase 1
- Pancreatic Neoplasms · Phase 1
- Salivary Gland Neoplasms · Phase 2
- Small Cell Lung Carcinoma · Phase 2
- Squamous Cell Carcinoma of Head and Neck · Phase 1/Phase 2
- Stomach Neoplasms · Phase 2
Mechanism of action
- Epidermal growth factor receptorANTAGONIST
Epidermal growth factor receptor antagonist
Epidermal growth factor receptor inhibitor
Including exon 20 deletions, C797S, T790M
- Hepatocyte growth factor receptorINHIBITOR
Hepatocyte growth factor receptor inhibitor
Approval history
- approvedPriority reviewAcceleratedBreakthroughMay 21, 2021
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- Yes
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- ChEMBLCHEMBL4297774 ↗
Also known as
- jnj-61186372
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07062354 | Phase 2 | Dec 31, 2025 | Janssen Pharmaceutica NV, SWOG Cancer Research Network |
| NCT07227025 | Phase 1/Phase 2 (Phase 2) | Dec 22, 2025 | — |
| NCT07042295 | Phase 2 | Dec 22, 2025 | National Cancer Institute (NCI), SWOG Cancer Research Network |
| NCT07276399 | Phase 3 | Dec 3, 2025 | — |
| NCT06855849 | Phase 2 | May 31, 2025 | Yonsei University |
| NCT06816992 | Phase 1 | Feb 27, 2025 | Johnson and Johnson, Oric Pharmaceuticals |
| NCT06750094 | Phase 3 | Dec 12, 2024 | — |
| NCT06667076 | Phase 2 | Nov 25, 2024 | — |
| NCT06784791 | Phase 2 | Nov 6, 2024 | University of Duisburg-Essen |
| NCT06662786 | Phase 3 | Oct 22, 2024 | — |
| NCT06632236 | Phase 1 | Oct 9, 2024 | Cancer Research UK, Janssen Pharmaceutica NV, Minderoo Foundation, National Health Service, United Kingdom, Royal Marsden Hospital NHS Trust, University of Cambridge, University of London |
| NCT06214403 | Phase 2 | Jul 31, 2024 | University of Toronto |
| NCT06532032 | Phase 1/Phase 2 (Phase 2) | Jul 23, 2024 | — |
| NCT06385080 | Phase 1/Phase 2 (Phase 2) | Apr 22, 2024 | — |
| NCT06120140 | Phase 2 | Mar 8, 2024 | — |
| NCT06083857 | Phase 1/Phase 2 (Phase 2) | Mar 1, 2024 | University of Texas at Houston |
| NCT06116682 | Phase 2 | Feb 16, 2024 | National Cancer Institute (NCI), SWOG Cancer Research Network |
| NCT05801029 | Phase 2 | Jul 18, 2023 | AstraZeneca, Parexel |
| NCT05845671 | Phase 1/Phase 2 (Phase 2) | Jul 11, 2023 | University of Colorado, Denver |
| NCT05908734 | Phase 1/Phase 2 (Phase 2) | May 18, 2023 | — |
Showing 20 of 44 trials
Page 1 / 3
Organizations
Research & Development (27)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Janssen Pharmaceutica NV | For profit | 13 | 7 | 4 | 2019 |
| NuBiyota | For profit | 4 | 4 | 2 | 2018 |
| SWOG Cancer Research Network | Academic/Hospital | 3 | 2 | 1 | 2024 |
| Johnson and Johnson | For profit | 2 | 1 | 1 | 2016 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 2 | 2 | 1 | 2021 |
| National Cancer Institute (NCI) | Government | 2 | 1 | 1 | 2024 |
| AstraZeneca | For profit | 1 | 1 | 1 | 2023 |
| Cancer Research UK | Academic/Hospital | 1 | 0 | 1 | 2024 |
| ETOP IBCSG Partners Foundation | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Fate Therapeutics | For profit | 1 | 1 | 1 | 2022 |
| Glycemic Index Laboratories, Inc | For profit | 1 | 0 | 1 | 2018 |
| Latin American Cooperative Oncology Group | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Minderoo Foundation | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Mount Sinai Hospital, Canada | Academic/Hospital | 1 | 0 | 1 | 2019 |
| National Health Service, United Kingdom | Government | 1 | 0 | 1 | 2024 |
| Oric Pharmaceuticals | For profit | 1 | 1 | 1 | 2025 |
| Parexel | For profit | 1 | 0 | 1 | 2023 |
| Queen's University, Belfast | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Royal Marsden Hospital NHS Trust | Academic/Hospital | 1 | 0 | 1 | 2024 |
| University of Cambridge | Academic/Hospital | 1 | 0 | 1 | 2024 |
27 organizations
Page 1 / 2
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Johnson and Johnson | For profit | MKTG | May 21, 2021 |
| Johnson and Johnson | For profit | NDA2 | May 21, 2021 |
| Johnson and Johnson | For profit | NDA | May 21, 2021 |