▎WuXiEdited by Kant Content Team

Johnson & Johnson today announced that the U.S. FDA has approved itsEGFR/METThe bispecific antibody amivantamab combined with the third-generation EGFR-TKI oral drug Lazcluze (lazertinib) forFirst-line treatment confirmed by FDA-approved testing to carryEGFRExon 19 deletion or exon 21L858RAdult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring substitution mutations.Previous trial results showed that, compared with the active control drug, this combination therapy reduced the risk of disease progression or death in patients by up to 30%.

In China, this combination therapy, namelyAmivantamab Injection (amivantamab)AndLanreotide Mesylate Tablets (lazertinib）Combination therapy has also alreadyDeclare for Market Launch, and was accepted by the NMPA in January 2024. Prior to that, inIn 2023,AmivantamabTwo marketing applications have been approved by the NMPA.Acceptance。

This FDA approval in the United States is mainly based on the positive results of the Phase 3 MARIPOSA clinical study, which examinedamivantamabAndlazertinibCombination Therapy withActive control TKI drug Tagrisso, used for first-line treatmentEGFREfficacy and safety in patients with locally advanced or metastatic NSCLC with exon 19 deletions or L858R substitution mutations in exon 21. The analysis shows,amivantamabAndlazertinibCompared with the active control drug, it can reduce the risk of disease progression or death by 30%.The median progression-free survival (PFS) for patients in the combination therapy group and the active comparator group was 23.7 months and 16.6 months, respectively.In addition,The median DOR of the combination therapy group was 9 months longer than that of the active control drug (25.8 months vs 16.7 months)., which was the secondary endpoint of the study.Combined TherapyThe safety profile is consistent with the known safety of each component.。

AmivantamabIt is a humanized EGFR/MET bispecific antibody.It has multiple mechanisms of anticancer action, not only blocking EGFR and MET-mediated signal transduction but also guiding immune cells to target tumors carrying activating and drug-resistant EGFR/MET mutations and amplifications.The ProductObtained FDA approval in the United States in May 2021Accelerated Approval, used to treat conditions detected by FDA-approved testsEGFRAdult patients with locally advanced or metastatic NSCLC who have exon 20 insertion mutations and whose disease has progressed during or after platinum-based chemotherapy.LazertinibIt is a highly selective, third-generation oral EGFR TKI capable of penetrating the blood-brain barrier.。