On October 26, the CDE website showed that Johnson & JohnsonEvanzumab Injection（amivantamab) The marketing application has been accepted by the NMPA, with a registration classification of 2.2.
Amivantamab 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, amivantamab received accelerated FDA approval for the treatment of patients with advanced or metastatic NSCLC carrying EGFR exon 20 insertion mutations whose disease has progressed after platinum-based chemotherapy. It is the world's first approved EGFR/c-MET bispecific antibody. Since the beginning of this year,Amivantamab has successively achieved positive results in multiple Phase III clinical trials.On July 17, Johnson & Johnson announced amivantamab in combination with chemotherapy(Carboplatin-Pemetrexed)Treatment of Newly Diagnosed EGConfirmatory Phase III PAPILLON Study in Patients with Advanced or Metastatic NSCLC Harboring FR Exon 20 Insertion MutationsThe results were positive, reaching the primary endpoint of PFS,Patients receiving combination therapy achieved a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to those receiving chemotherapy alone.On September 6, Johnson & Johnson announced that the Phase III MARIPOSA-2 study of amivantamab in combination with Lazertinib and chemotherapy for the treatment of osimertinib resistance has achievedDual primary endpoints: Compared with the chemotherapy-alone group, both trial groups showed statistically significant and clinically meaningful improvements in PFS.ThisYesThe first Phase III study to demonstrate a clinically meaningful improvement in PFS with osimertinib as a later-line treatment.On September 28, Johnson & Johnson announced againamivantamabUnitedLazertinib Head-to-Head with Osimertinib in the Treatment of EGFR-Mutated Locally Advanced or Metastatic NSCLC: Phase III MARIPOSA Study Meets Primary EndpointAndOsimertinib Treatment GroupIn comparison,amivantamab+Lazertinib treatment group showed statistically significant and clinically meaningful improvement in PFS, along with a trend toward OS benefit.Copyright © 2023 PHARMCUBE. All Rights Reserved.
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