The FDA has granted an accelerated approval to amivantamab-vmjw (Rybrevant) for the patients with luing cancer

On May 21, 2021, the FDA has granted an accelerated approval to amivantamab-vmjw (Rybrevant) for the patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutation.

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Approximately, 4% of NSCLC patients with EGFR mutation has exon 20 insertion mutation (ex20ins), and these patients do not respond to any EGFR inhibitors currently available.

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The approval was based on the phase 1 trial, CHRYSALIS (NCT02609776), in which the efficacy of amivantamab was tested in 81 patients with advanced NSCLC with ex20ins whose cancer was progressed after platinum-based chemotherapy. Forty percent of patients were responded to the drug for median 11.1 months.

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Its regular approval is contingent upon further verification of its efficacy in the confirmatory trials. The phase 2 study is ongoing to further evaluate its safety and efficacy. To check your eligibility for the clinical trials of amivantamab, please discuss with your oncologists or contact us at minji@MJpatientadvocate.com