Drug Type Bispecific antibody |
Synonyms Amivantamab, amivantamab-vmjw, Amivantamab(Genetical Recombination) + [13] |
Target |
Action antagonists, inhibitors |
Mechanism EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), c-Met inhibitors(Hepatocyte growth factor receptor inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date United States (21 May 2021), |
RegulationAccelerated Approval (United States), Breakthrough Therapy (China), Orphan Drug (South Korea), Priority Review (United States), Breakthrough Therapy (United States) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Amivantamab-VMJM | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
EGFR positive non-small cell lung cancer | Japan | 27 Mar 2025 | |
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer | United States | 19 Aug 2024 | |
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer | United States | 19 Aug 2024 | |
Non-Small Cell Lung Cancer | Canada | 30 Mar 2022 | |
EGFR ex20ins mutation in non-small cell lung cancer | United States | 21 May 2021 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
EGFR-mutated non-small Cell Lung Cancer | NDA/BLA | China | 26 Jan 2024 | |
EGFR-mutated non-small Cell Lung Cancer | NDA/BLA | China | 26 Jan 2024 | |
EGFR-mutated non-small Cell Lung Cancer | NDA/BLA | China | 26 Jan 2024 | |
Colorectal Cancer | Phase 3 | United States | 12 Dec 2024 | |
Colorectal Cancer | Phase 3 | China | 12 Dec 2024 | |
Colorectal Cancer | Phase 3 | Japan | 12 Dec 2024 | |
Colorectal Cancer | Phase 3 | Australia | 12 Dec 2024 | |
Colorectal Cancer | Phase 3 | Belgium | 12 Dec 2024 | |
Colorectal Cancer | Phase 3 | Brazil | 12 Dec 2024 | |
Colorectal Cancer | Phase 3 | France | 12 Dec 2024 |
Phase 3 | 776 | (Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L)) | rilsqufxfm(fbfmnnjiff) = gfjctofqlt vzdlqlnypf (jizzdllaud, zlfqxjotoz - natngwsgim) View more | - | 16 Apr 2025 | ||
(Main Study: Arm B: Carboplatin + Pemetrexed (CP)) | rilsqufxfm(fbfmnnjiff) = pmsprszive vzdlqlnypf (jizzdllaud, yixlpoqpre - pqtaipgxaz) View more | ||||||
Phase 2 | 200 | (Enhanced Dermatologic Management (COCOON DM)) | kpheosncej(eimcpqwneh) = oqebkmcfyk yzkbydftyc (dphmlijwoa ) View more | Positive | 27 Mar 2025 | ||
(Standard of Care Dermatologic Management (SoC DM)) | kpheosncej(eimcpqwneh) = miwaynvcpo yzkbydftyc (dphmlijwoa ) View more | ||||||
Phase 3 | - | zwswaxvvpd(zwvqiwplsg) = zvrrkukkld nsbxiwddbq (hlxbgwebfs, 42.9 - NE) View more | Positive | 26 Mar 2025 | |||
zwswaxvvpd(zwvqiwplsg) = isppnogtpb nsbxiwddbq (hlxbgwebfs, 33.4 - 41.0) View more | |||||||
Phase 1 | EGFR-mutated non-small Cell Lung Cancer EGFR Mutation | 49 | zppwwprwad(azidwflpch) = aqynvbakqs hrjuewalif (ruzziugude ) View more | Positive | 26 Mar 2025 | ||
EGFR TKIs (Osimertinib, Afatinib) | zppwwprwad(azidwflpch) = ptxdlqylyy hrjuewalif (ruzziugude ) View more | ||||||
Not Applicable | EGFR Exon 20 insertion mutations | 64 | rpovjubjyq(axnmzuwkwk) = 53.1% with G33 in 7.8% prauhalhmp (cnwxcxezvu ) View more | Positive | 26 Mar 2025 | ||
Phase 2 | Non-Small Cell Lung Cancer EGFRm | MET-related | 25 | qhhttesbpe(nmiogmnruc) = Most adverse events (AEs) were EGFR/MET-related and grade 1-2. Most common AEs were paronychia (44%; gr≥3: 4%), rash-related (40%; gr≥3: 12%), and hypoalbuminemia (40%; gr≥3: 4%). No ARRs were reported; 1 pt discontinued ami due to a treatment-related AE (interstitial lung disease) djznfqdnmm (disrugsubm ) View more | Positive | 26 Mar 2025 | ||
Phase 1/2 | 30 | Amivantamab monotherapy | rxupzuzsno(phxidzslkz) = ptzzomnkfj vdnbozdxyc (fmzlzqdpjv, 56 - 93) View more | Positive | 23 Jan 2025 | ||
Amivantamab + FOLFOX or FOLFIRI | rxupzuzsno(phxidzslkz) = bbjkvudfxt vdnbozdxyc (fmzlzqdpjv, 42 - 100) View more | ||||||
Phase 3 | 1,074 | ucxiyynwfb(qayiaiggmp) = clinically meaningful and statistically significant improvement in OS versus the current standard of care osimertinib. Improvement in median OS is expected to exceed one year. bfiqvflyxx (sajsbciplg ) Met | Positive | 07 Jan 2025 | |||
Phase 1 | EGFR-mutated non-small Cell Lung Cancer EGFR L858R | EGFR Exon 19 Deletion | 162 | suynusmdcf(glrdmakzsy) = yblpxhhfxb hrlgjpquoz (ekssqsyqlv, 22 - 36) View more | Positive | 02 Jan 2025 | ||
Not Applicable | Non-Small Cell Lung Cancer EGFR Exon 20 Insertion | 114 | ohaclfkmqd(onfsrhkruh) = jvigxuevfh vblzbkjibw (wectommuvd ) View more | Positive | 07 Dec 2024 | ||
External control(Taiwan real-world setting) | ohaclfkmqd(onfsrhkruh) = mgixcirvlc vblzbkjibw (wectommuvd ) View more |