On March 1, Johnson & Johnson announced that after a priority review, the FDA had approved Rybrevant (amivantamab-vmjw).Combination Chemotherapy (Carboplatin-Pemetrexed) as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring EGFR Exon 20 Insertion MutationsThe FDA's action this time also converted the accelerated approval of Rybrevant in May 2021 into a full approval based on the confirmatory Phase III PAPILLON study.The press release shows that Rybrevant is the first targeted therapy approved by the FDA for first-line treatment of NSCLC patients with EGFR exon 20 insertion mutations.The results showed,Compared with chemotherapy alone, Rybrevant combined with chemotherapy reduced the risk of disease progression or death by 61%, andImproved ORR and PFS.Based on the PAPILLON study data,National Comprehensive Cancer Network (NCCN))Updated NCCN Clinical Practice Guidelines, RecommendedRybrevant Combined with Chemotherapy as the Preferred First-Line Treatment for NSCLC Patients with EGFR Exon 20 Insertion Mutations.Rybrevant is a bispecific antibody that targets EGFR resistance mutations, MET mutations, and amplifications. It can simultaneously bind to the extracellular structures of EGFR and c-Met, block the binding of ligands to EGFR and MET, promote receptor degradation, and trigger antibody-dependent cellular cytotoxicity.In May 2021, based on data from the Phase I CHRYSALIS study Rybrevant monotherapy cohort,The product received FDA accelerated approval for the treatment of metastatic NSCLC patients with EGFR exon 20 insertion mutations who have progressed after platinum-based chemotherapy.In December of the same year, Rybrevant received conditional approval in the EU.In November 2023, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA for Rybrevant in combination with chemotherapy to treat patients with EGFR-mutated non-small cell lung cancer (NSCLC) whose disease has progressed during or after treatment with osimertinib.In December 2023, Johnson & Johnson submitted a new indication marketing application for Rybrevant to the U.S. FDA and European EMA, for first-line treatment of patients with EGFR-mutated locally advanced or metastatic NSCLC in combination with the third-generation EGFR inhibitor Lazertinib.In October 2023, Johnson & Johnson submitted to the NMPARybrevantThe first marketing application, expected to launch in China by Q4 2024.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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