Johnson & Johnson Reports the US FDA’s Approval of Rybrevant + Lazcluze as a 1L Treatment of NSCLC with EGFR Mutations 

Shots:    

• The US FDA has approved J&J’s Rybrevant + Lazcluze as a 1L treatment for LA/metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations 

• The approval was based on the P-III (MARIPOSA) assessing Rybrevant + lazertinib vs osimertinib and lazertinib alone in 1074 patients 

• The study reached its 1EP and 2EPs vs osimertinib that shows mPFS (23.7mos. vs 16.6mos.) & 2EP shows mDOR (25.8mos. vs 16.7mos.). These data were presented at the ESMO 2023 & ASCO 2024 and published in the NEJM & Annals of Oncology 

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

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