Johnson & Johnson's Rybrevant Scores Third FDA-Approval Of 2024 For Certain Type Of Inoperable Lung Cancer In Pretreated Patients

Thursday, the FDA approved Johnson & Johnson (NYSE:JNJ) Rybrevant (amivantamab-vmjw) in combination with standard-of-care chemotherapy (carboplatin and pemetrexed) for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.

The FDA approval is based on results from the Phase 3 MARIPOSA-2 study, which showed that Rybrevant plus chemotherapy reduced the risk of disease progression or death (progression-free survival [PFS]) by 52% compared to chemotherapy alone, the study’s primary endpoint.

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