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Rybrevant
Published
Product name
Rybrevant
Active ingredient
Amivantamab
Submission type
New biological entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Rybrevant (amivantamab) was approved for the following therapeutic use:
The provisionally approved new indication(s) for the medicine(s) are:
Rybrevant has provisional approval for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has an activating epidermal-growth factor receptor (EGFR) exon 20 insertion mutation, whose disease has progressed on or after platinum-based chemotherapy.
The decision to approve this indication has been made on the basis of objective response rate and duration of response in a single arm study. Continued approval of this indication depends on verification and description of benefit in a confirmatory study.
The full indications are now:
Rybrevant has provisional approval for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has an activating epidermal-growth factor receptor (EGFR) exon 20 insertion mutation, whose disease has progressed on or after platinum-based chemotherapy.
The decision to approve this indication has been made on the basis of objective response rate and duration of response in a single arm study. Continued approval of this indication depends on verification and description of benefit in a confirmatory study.
How this medicine works
Amivantamab is a low-fucose, fully-human immunoglobulin G1(IgG1)-based bispecific antibody that binds to the extracellular domains of epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (MET).
In preclinical studies, amivantamab disrupted EGFR and MET signalling functions through blocking ligand binding and, in exon 20 insertion mutation models, enhancing degradation of EGFR and MET. The presence of EGFR and MET on the surface of tumour 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.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Rybrevant was considered favourable for the therapeutic use approved.
Sponsor