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On May 21, the FDA accelerated the approval of Johnson & Johnson's EGFR/c-Met dual antibody Rybrevant (amivantamab-vmjw) for the treatment of metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations that have progressed after platinum-based chemotherapy Patient
.
This is the first drug approved by the FDA for this type of mutation
Amivantamab was granted a breakthrough therapy qualification for this type of patient by the FDA in March 2020, and submitted a marketing application to the FDA on December 3 last year based on phase I clinical data.
It was the first to submit a marketing application to a regulatory agency.
Drugs for the treatment of such patients
.
Amivantamab was granted breakthrough therapy qualification by CDE in September 2020
.
Currently in China, Betta Pharmaceuticals, Jiahe Biological, and Anmai Biological are also developing EGFR/c-Met dual-antibody drugs
