Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 85 |
| INN | Amivantamab |
| Status | Approved |
| Drug code(s) | JNJ-61186372, EM1-mAb |
| Brand name | Rybrevant |
| mAb sequence source | mAb human |
| General Molecular Category | Bispecific |
| Format, general category | Full length Ab |
| Format details | Duobody |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | DuoBody platform |
| Target(s) | EGFR, cMET |
| Indications of clinical studies | Colorectal cancer, non-small cell lung cancer, gastric or esophageal cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia, Canada |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | February 15, 2016 |
| Start of Phase 2 | |
| Start of Phase 3 | September 30, 2020 |
| Date BLA/NDA submitted to FDA | November 24, 2020 |
| Year of first approval (global) | 2021 |
| Date of first US approval | May 21, 2021 |
| INN, US product name | Amivantamab; amivantamab-vmjw |
| US or EU approved indications | First-line treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations. |
| Company | Genmab |
| Licensee/Partner | Janssen Research & Development |
| Comments about company or candidate | Approved in EU on Dec 10, 2021. Oct 2021: Genmab announces that Janssen has received positive CHMP opinion for RYBREVANT (amivantamab) for patients with advanced non-small cell lung cancer with EGFR Exon 20 insertion mutations, after failure of platinum-based therapy On December 3, 2020, The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Biologics License Application to the U.S. Food and Drug Administration (FDA) seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. NCT04538664 Phase 3 in NSCLC not yet recruiting when posted on Sep 4, 2020. NCT04487080 Phase 3 in NSCLC started in Sep 30, 2020. As of April 14, 2020 update, Janssen plans to submit marketing applications in US/EU in 2020. Listed as Phase 2 in pipeline update dated April 14, 2020, but no Phase 2 studies are listed on clinicaltrials.gov. March 12, 2020: FDA grants breakthrough therapy designation for treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. NCT04077463 Phase 1 study in in Japanese Participants With Advanced Non-small Cell Lung Cancer not yet recruiting patients as of record posting on Sep 4 2019. Listed in Janssen pipeline dated July 16, 2019. The Applicant submitted IND 135405 on 20 October 2017 to the US Food and Drug Administration (FDA) to support the investigation of amivantamab in the treatment of advanced or refractory solid malignancies NCT02609776 Phase 1 in NSCLC started in March 2016. |
| Full address of company | Copenhagen, Denmark Europe Denmark https://www.genmab.com/ |
IgG assembled from half-antibodies. EM1-mAb is under development for the treatment of non-small-cell lung cancer (NSCLC). The drug candidate is a monoclonal antibody and targets EGFr and cMet. It is administered intravenously. The drug candidate is based on DuoBody technology platform, a monoclonal antibody technology. Engineered with low fucosylation (<10%) resulting in enhanced ADCC activity and FcyRIIIa binding. Produced in CHO cells. K409R; F405L mutations
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |