AMIVANTAMAB-VMJW

Other

Brand names: Rybrevant

Intravenous

Mechanism of Action

12.1 Mechanism of Action Amivantamab-vmjw is a bispecific antibody that binds to the extracellular domains of EGFR and MET. In in vitro and in vivo studies amivantamab-vmjw was able to disrupt EGFR and MET signaling functions in mutation models of exon 19 deletions, exon 21 L858R substitutions, and exon 20 insertions through blocking ligand binding or degradation of EGFR and MET. The presence of EGFR and MET on the surface of tumor cells also allows for targeting of these cells for destruction by immune effector cells, such as natural killer cells and macrophages, through antibody-dependent cellular cytotoxicity (ADCC) and trogocytosis mechanisms, respectively. Treatment with amivantamab in combination with lazertinib increased in vivo anti-tumor activity compared to either agent alone in a mouse xenograft model of human NSCLC with an EGFR L858R mutation.

Indications

as detected by an FDA-approved test. ( 1

2.2 ) in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations

whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. ( 1

2.2 ) in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations

as detected by an FDA-approved test. ( 1

2.2 ) as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Infusion-Related Reactions (IRR) : Interrupt infusion at the first sign of IRRs
Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception
Administer RYBREVANT via a peripheral line on Week 1 and Week 2 to reduce the risk of infusion-related reactions [see Dosage and Administration (2
2 Interstitial Lung Disease/Pneumonitis RYBREVANT can cause severe and fatal interstitial lung disease (ILD)/pneumonitis

Known Side Effects

5 documented side effects by frequency

Rash

>10%

Shortness of Breath

1-10%

Nausea

0.1-1%

Fatigue

0.1-1%

Low Blood Pressure

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous