Amivantamab-vmjw is an EGFR- and MET-directed bispecific antibody marketed as Rybrevant for specific EGFR-mutated non-small cell lung cancer settings. FDA first granted accelerated approval in 2021 for post-platinum EGFR exon 20 insertion disease and subsequently expanded approvals into first-line combination regimens in 2024. It is an approved targeted biologic for adult NSCLC populations selected by molecular testing.
The FDA approved once-monthly subcutaneous amivantamab with lazertinib for first-line EGFR-mutated advanced NSCLC. PALOMA-2 showed high response rates and no new safety signals.
Heather Quintana Suchan said early biomarker testing and genomic profiling identified an exon 20 mutation and helped match her to Rybrevant for stage 4 lung cancer. She said the treatment is working well with minimal side effects and is urging patients to seek personalized testing early.
The U.S. FDA granted Breakthrough Therapy Designation for subcutaneous Rybrevant Faspro as monotherapy for adults with advanced head and neck squamous cell carcinoma, based on Phase 1b/2 study data showing rapid and durable responses.
The FDA has approved a monthly dosing schedule for Rybrevant Faspro in EGFR-mutated NSCLC and granted breakthrough therapy designation for the drug as monotherapy in HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma after prior therapy.
The FDA approved a once-monthly dosing schedule for Rybrevant Faspro with Lazcluze for first-line treatment of EGFR-mutated advanced NSCLC, reducing clinic visits while maintaining safety and efficacy established with bi-weekly dosing.
