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On May 21, the FDA issued an announcement to accelerate the approval of Johnson & Johnson's Rybrevant (amivantamab-vmjw) for patients with metastatic non-small cell lung cancer (NSCLC) who have advanced EGFR exon 20 insertion mutations after platinum-based chemotherapy.
The approval is based on data from the CHRYSALIS study.
The main efficacy endpoint is the overall response rate (ORR) and duration of response assessed by BICR according to RECIST 1.
The most common adverse reactions (≥20%) are skin rash, infusion-related reactions, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation and vomiting.
Amivantamab (R&D code: JNJ-61186372) is an EGFR/c-Met double antibody developed by Johnson & Johnson.
From: CDE official website
According to the Insight database, Johnson & Johnson launched the EGFR/c-Met dual-antibody Amivantamab Phase III clinical trial in China in December last year, combined with the third-generation EGFR inhibitor Lazertinib for the first-line treatment of advanced unresectable NSCLC.
From: Insight database (http://db.
At present, in China, EGFR/c-Met dual antibodies, Betta Pharmaceuticals and Anmai Bio are in clinical development, and both of them have started a phase I/II clinical trial.
Overview of domestic progress of EGFR/c-Met dual antibodies (Insight)
