Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EGFR Exon 20 (Insertion) status confers therapeutic sensitivity to Amivantamab in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug Administration granted approval to amivantamab-vmjw for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
This statement is based on a regulatory approval from the Food and Drug Administration:
RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.