Initial US Approval
20211
Indications
- In combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon20 insertion (EGFRex20ins) mutations, as detected by an FDA-approved test.1
- As a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFRex20ins mutations, as detected by an FDA-approved test.1
Recommended Dose/Route
- Amivantamab is administered by intravenous infusion until disease progression or unacceptable toxicity.1
- Premedications are recommended prior to initial infusion to reduce the risk of infusion-related reactions.1
Dose Reductions for Adverse Reactions
Pivotal Studies
Safety
References
1. Janssen. Rybrevant (Amivantamab). Package Insert. 2024. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT-pi.pdf?#page=10
2. Zhou C, Tang K-J, Cho BC, et al. Amivantamab plus chemotherapy in NSCLC with EGFR exon 20 insertions. N Engl J Med. 2023;389(22):2039-2051. doi:10.1056/NEJMoa2306441
3. Park K, Haura EB, Leighl NB, et al. Amivantamab in EGFR exon 20 insertion-mutated non-small-cell lung cancer progressing on platinum chemotherapy: initial results from the CHRYSALIS phase I study. J Clin Oncol. 2021;39(30):3391-3402. doi: 10.1200/JCO.21.00662