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Johnson & Johnson Gains the CHMP’s Positive Opinion for Rybrevant (Amivantamab) as a 1L Treatment of NSCLC  

Shots: 

  • The company’s Rybrevant + CT (carboplatin & pemetrexed) has gained the CHMP’s positive opinion as a 1L therapy for NSCLC associated with activating EGFR exon 20 insertion mutations  
  • The opinion was based on the P-III (PAPILLON) trial assessing the safety & efficacy of Rybrevant + CT vs CT in NSCLC patients (n=308) with EGFR exon 20 insertion mutations that showed improved PFS (1EP) & a trend favoring interim OS. 7% TRAEs leading to discontinuation 
  • Rybrevant is a bispecific Ab targeting activated & resistant EGFR mutation as well as MET mutations and amplifications 

Ref:Johnson & Johnson  | Image: Johnson & Johnson| Press Release

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