August 2021: The FDA granted amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.), a bispecific antibody directed against epidermal growth factor (EGF) and MET receptors, accelerated approval for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.
The Guardant360® CDx (Guardant Health, Inc.) has also been approved by the FDA as a companion diagnostic for amivantamab-vmjw.
CHRYSALIS, a multicenter, non-randomized, open label, multicohort clinical trial (NCT02609776) that included patients with locally advanced or metastatic NSCLC who had EGFR exon 20 insertion mutations, was used to gain approval. Efficacy was assessed in 81 patients with advanced NSCLC who had EGFR exon 20 insertion mutations and had progressed after platinum-based treatment. Amivantamab-vmjw was given to patients once a week for four weeks, then every two weeks until disease progression or unacceptable toxicity.
Overall response rate (ORR) according to RECIST 1.1 as assessed by blinded independent central review (BICR) and response duration were the key efficacy outcome measures. With a median response time of 11.1 months, the ORR was 40% (95 percent CI: 29 percent, 51 percent) (95 percent CI: 6.9, not evaluable).
Rash, infusion-related responses, paronychia, musculoskeletal pain, dyspnea, nausea, exhaustion, edoema, stomatitis, cough, constipation, and vomiting were the most prevalent side events (20%).
The recommended dose of amivantamab-vmjw is 1050 mg for patients with a baseline body weight of less than 80 kg and 1400 mg for those with a baseline body weight of more than 80 kg, given weekly for four weeks and then every two weeks until disease progression or unacceptable toxicity occurs.
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