Amivantamab (Rybrevant)

==General information==
Class/mechanism from the NCI Drug Dictionary: A human bispecific antibody targeting both epidermal growth factor receptor EGFR and hepatocyte growth factor receptor (HGFR; cMet), with potential antineoplastic activity. Upon administration, amivantamab simultaneously targets and binds to wild-type or certain mutant forms of both EGFR and cMet expressed on cancer cells, thereby preventing receptor phosphorylation. This prevents the activation of both EGFR- and cMet-mediated signaling pathways. In addition, binding results in receptor degradation, which further inhibits EGFR- and cMet-mediated signaling. JNJ-61186372 also causes antibody-dependent cellular cytotoxicity (ADCC). Altogether, this results in the inhibition of tumor cell proliferation.
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information.
==Diseases for which it is used==
*Non-small cell lung cancer, EGFR-mutated
==Patient drug information==
To be completed
==History of changes in FDA indication==
*2021-05-21: Granted accelerated approval for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. (Based on CHRYSALIS)
**2024-03-01: Converted to regular approval for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. (Based on PAPILLON)
*2024-03-01: Approved with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. (Based on PAPILLON)
*2024-09-19: Approved with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. (Based on MARIPOSA-2)
==History of changes in EMA indication==
*2021-12-09: Initial conditional approval as Rybrevant as monotherapy for treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, after failure of platinum-based therapy.
==History of changes in Health Canada indication==
*2022-03-30: Initial notice of compliance with conditions for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
==Also known as==
*Code name: JNJ-61186372
*Generic name: amivantamab-vmjw
*Brand name: Rybrevant
==References==
Category:Drugs
Category:Intravenous medications
Category:Mutation-specific medications
Category:Anti-EGFR-HGFR bispecific antibodies
Category:Non-small cell lung cancer medications
Category:EMA approved in 2021
Category:FDA approved in 2021
Category:Health Canada approved in 2022