▎WuXiEdited by Kant Content Team

Johnson & Johnson today announced that the U.S. FDA has fully approved its bispecific antibody Rybrevant (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors are confirmed to have epidermal growth factor receptor (EGFR) mutations by an FDA-approved test.EGFR) Exon 20 insertion mutation.According to the press release,RybrevantCombination chemotherapy is the first therapy approved by the FDA for treating this patient population.

This FDA approval is mainly based on the positive results of the randomized, open-label, Phase 3 confirmatory trial PAPILLON. The study shows that,Compared with chemotherapy alone, Rybrevant combined with chemotherapy reduced the risk of disease progression or death by 61%.The results also showed that Rybrevant combined with chemotherapy improved patients' objective response rate (ORR) and progression-free survival (PFS). According to the PAPILLON trial data,The National Comprehensive Cancer Network (NCCN) has updated its "NCCN Clinical Practice Guidelines" to recommend Rybrevant in combination with chemotherapy as a first-line treatment for NSCLC patients whose tumors carryEGFRExon 20 insertion mutation.

The safety of the combination therapy of Rybrevant and chemotherapy is related to each component.Consistent safety.

Rybrevant 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. Rybrevant received approval from the U.S. FDA in May 2021.Accelerated 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.

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