Johnson & Johnson’s Rybrevant Plus Lazcluze Receives the CHMP’s Positive Opinion as a 1L Treatment of EGFR-Mutated NSCLC
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The CHMP has recommended Rybrevant + Lazcluze as a 1L treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations and approval of Type II extension of indication for amivantamab
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Opinion was based on the P-III (MARIPOSA) study assessing Rybrevant + Lazcluze vs osimertinib & Lazcluze in NSCLC patients (n=1,074)
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Trial achieved its 1EP, showing a 30% reduced disease progression or death risk (mPFS: 23.7 vs 16.6mos.) at 22mos. follow-up & mDoR of 25.8 vs 16.8mos. It also included serial brain MRIs to detect CNS events & depicted mPFS of 27.5 vs 18.4mos.; long-term follow-up (31.1mos.) showed a favorable OS trend, with 61% vs 53% alive, mOS not estimable [NE] vs 37.3mos.
Ref: Johnson | Image: Johnson
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
