Johnson & Johnson (JNJ.US) receives approval for EGFR/c-Met dual targeted therapy combined with chemotherapy as a second-line treatment for NSCLC.

On September 20, Johnson & Johnson (JNJ.US) announced that the FDA has approved its EGFR/c-Met bispecific antibody Rybrevant (amivantamab-vmjw) in combination with standard chemotherapy (carboplatin plus pemetrexed) from United Therapeutics Corporation for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion (ex19del) or L858R substitution mutations, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. Rybrevant is a fully human bispecific antibody targeting EGFR and MET, with immune cell-directed activity. This approval follows previous approvals of Rybrevant for the first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations in March and for the first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations in combination with the third-generation EGFR inhibitor Lazcluze (lazertinib) in August, marking the third new indication approved this year. Dr. Kiran Patel, Vice President of Medical Affairs and Clinical Development at Johnson & Johnson, said, "This milestone strengthens Rybrevant as an important treatment option for patients with EGFR-mutated NSCLC, who continue to have high unmet needs after disease progression on or after TKI therapy."