Jul 10, 2021
FDA OKs Bispecific Antibody for Rare Lung Cancer Subtype
Posted by Jason Blain in category: biotech/medical
The overall response rate in the trial population was 40% (95% CI 29%-51%). Median duration of response was 11.1 months (95% CI 6.9-not evaluable), with nearly two-thirds of patients having a duration of response of at least 6 months.
The FDA approved amivantamab-vmjw (Rybrevant) on Friday as the first treatment for patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.
Amivantamab is a bispecific antibody that targets EGFR and mesenchymal-epithelial transition factor pathways. EGFR exon 20 insertion mutations occur in approximately 2% to 3% of NSCLC patients, and are associated with rapid cell growth.
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