According to the NCI Economic Intelligence APP, on September 20, Johnson & Johnson (JNJ.US) announced that the FDA has approved its EGFR/c-Met dual antibody Rybrevant (amivantamab-vmjw, evantamab-vmjw, evantamab-vmjw) in combination with standard chemotherapy (carboplatin + pemetrexed) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients with EGFR exon 19 deletion (ex19del) or L858R substitution mutations who have progressed during or after EGFR tyrosine kinase inhibitor (TKI) therapy.

It is reported that Rybrevant is a fully human bispecific antibody targeting EGFR and MET with immune cell-directed activity. This approval follows the FDA's approval of Rybrevant in March of this year for the first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, and the FDA's approval in August of this year of its combination with the third-generation EGFR inhibitor Lazcluze (lazertinib) as a first-line treatment for locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations. This is the third new indication approved this year.

Dr. Kiran Patel, Vice President of Clinical Development for Johnson & Johnson Innovation Medicine, said, "This milestone strengthens Rybrevant as an important treatment option for patients with EGFR-mutated NSCLC, who continue to have a highly unmet need after progression during or after TKI therapy."