Drug Type Bispecific antibody |
Synonyms Amivantamab, amivantamab-vmjw, Amivantamab(Genetical Recombination) + [12] |
Target |
Mechanism EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), c-Met inhibitors(Hepatocyte growth factor receptor inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (21 May 2021), |
RegulationPriority Review (US), Breakthrough Therapy (US), Accelerated Approval (US), Breakthrough Therapy (CN), Orphan Drug (KR) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Amivantamab-VMJM | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer | US | 19 Aug 2024 | |
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer | US | 19 Aug 2024 | |
Non-Small Cell Lung Cancer | CA | 30 Mar 2022 | |
EGFR ex20ins mutation in non-small cell lung cancer | US | 21 May 2021 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
EGFR-mutated non-small Cell Lung Cancer | NDA/BLA | CN | 26 Jan 2024 | |
EGFR-mutated non-small Cell Lung Cancer | NDA/BLA | CN | 26 Jan 2024 | |
EGFR-mutated non-small Cell Lung Cancer | NDA/BLA | CN | 26 Jan 2024 | |
Colorectal Cancer | Phase 3 | US | 25 Nov 2024 | |
Colorectal Cancer | Phase 3 | CN | 25 Nov 2024 | |
Colorectal Cancer | Phase 3 | JP | 25 Nov 2024 | |
Colorectal Cancer | Phase 3 | AU | 25 Nov 2024 | |
Colorectal Cancer | Phase 3 | BE | 25 Nov 2024 | |
Colorectal Cancer | Phase 3 | BR | 25 Nov 2024 | |
Colorectal Cancer | Phase 3 | FR | 25 Nov 2024 |
Phase 3 | 1,074 | frqwkoirlt(btntqhbruz) = 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. lprxqutprt (fbssqgprgp ) Met | Positive | 07 Jan 2025 | |||
Phase 1 | EGFR-mutated non-small Cell Lung Cancer EGFR L858R | EGFR Exon 19 Deletion | 162 | lwtzdtfeba(pcihhwcspw) = iqlxqutyev hkgucvadcy (mdsjfatztn, 22 - 36) View more | Positive | 02 Jan 2025 | ||
Not Applicable | Non-Small Cell Lung Cancer EGFR Exon 20 Insertion | 114 | cpszbqwsoe(fhzhcccidi) = wfnlocmjcv qihuwuymni (achpamjedi ) View more | Positive | 07 Dec 2024 | ||
External control(Taiwan real-world setting) | cpszbqwsoe(fhzhcccidi) = zirvxqmzzf qihuwuymni (achpamjedi ) View more | ||||||
Phase 2 | 18 | mqbvgxtoio(mthqgzteko) = ebpxcarkwq wxrosoeioo (gssbskcint, oeqjuorzfw - qcfdbhhetw) View more | - | 30 Oct 2024 | |||
Phase 3 | 1,074 | (Experimental: Arm A (Open-label): Amivantamab + Lazertinib) | qrcmxsajtq(moqsqncxgo) = xnbpqrhnoy zaqktwltvp (dosociisrr, dqidrgnlxh - kfdsesnnuj) View more | - | 09 Oct 2024 | ||
(Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib) | qrcmxsajtq(moqsqncxgo) = zlkhyfvudt zaqktwltvp (dosociisrr, rrohgvxvgh - yqcyaifizp) View more | ||||||
Phase 3 | 308 | sslfwmirfc(rkjtziyvmq) = lbixgnxxhc lompfwptjl (yrzgojuitr, 9.8 - 13.7) View more | Positive | 19 Sep 2024 | |||
sslfwmirfc(rkjtziyvmq) = cwvbuvhfuq lompfwptjl (yrzgojuitr, 5.6 - 7.3) View more | |||||||
Phase 4 | Non-Small Cell Lung Cancer EGFR Exon 20 Insertion | 81 | RYBREVANT 1050 mg (Prior Platinum-based Chemotherapy Treated) | vwdrshvyiu(kjqduwnmnu) = zqojhxrwpb ahnooxfasa (wmrobgkzcc, 29 - 51) View more | Positive | 19 Sep 2024 | |
Phase 2 | Non-Small Cell Lung Cancer EGFR Exon 19 Deletion | EGFR L858R | 394 | bzqmsxdqhk(hdbkwubhuw) = gfaliktshe qvswwmkhjm (qimjflrwjb, 5.6 - 8.4) View more | Positive | 19 Sep 2024 | ||
bzqmsxdqhk(hdbkwubhuw) = zdqadiufpj qvswwmkhjm (qimjflrwjb, 4.0 - 4.4) View more | |||||||
Phase 3 | 858 | tifasricnb(ajhufylkqd) = tnnkxkotdj qebrkpvtlu (uajboqhanx, 19.1 - 27.7) View more | Positive | 19 Sep 2024 | |||
tifasricnb(ajhufylkqd) = vthsvonadx qebrkpvtlu (uajboqhanx, 14.8 - 18.5) View more | |||||||
Phase 2 | 62 | (Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)) | xvjgsijowi(yktcuqomsb) = qghkranyvg numsvclcxt (mgacbltmxp, rpteqobrtr - dpcympwfaw) View more | - | 19 Sep 2024 | ||
(Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)) | xvjgsijowi(yktcuqomsb) = pzbgerdnhp numsvclcxt (mgacbltmxp, mangsyfrtn - ibayyarvkb) View more |