J&J Seeking Approval of RYBREVANT Plus Lazertinib for Non-Small Cell Lung Cancer

 Submissions supported by data from landmark Phase 3 MARIPOSA study, which showed statistically significant and clinically meaningful improvement in progression-free survival in patients with EGFR-mutated advanced NSCLC treated with RYBREVANT® plus lazertinib versus osimertinib

Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) together with a New Drug Application (NDA) seeking the approval of RYBREVANT® (amivantamab-vmjw) in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution mutations, as detected by an FDA-approved test. Based on the Phase 3 MARIPOSA study, this marks the third submission from the RYBREVANT® clinical development program in four months, following sBLA submissions for MARIPOSA-2 and PAPILLON.

https://www.prnewswire.com/news-releases/johnson--johnson-submits-supplemental-biologics-license-application-and-new-drug-application-to-us-fda-seeking-approval-of-rybrevant-amivantamab-vmjw-plus-lazertinib-for-the-treatment-of-patients-with-egfr-mutated-non-small--302020967.html