Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EGFR Exon 19 (Deletion) status confers therapeutic sensitivity to Amivantamab, Carboplatin, Pemetrexed in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug administration granted approval to amivantamab-vmjw in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
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 in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.