Johnson & Johnson Receives the CHMP Positive Opinion on Label Extension to SC Rybrevant for the Treatment of Advanced EGFR-Mutated NSCLC
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- The CHMP recommended label extension to SC Rybrevant (Q1W x 4wks, then Q2W) + Lazcluze for 1L advanced NSCLC harboring EGFRm exon 19 del/ exon 21 L858R substitution & as monotx. for NSCLC pts with EGFRm exon 20 insertions unresponsive to Pt-based CT
- Opinion was backed by P-III (PALOMA-3) trial, evaluating SC vs IV RoA of Rybrevant + Lazcluze in advanced or metastatic EGFRm NSCLC pts whose disease progressed on Tagrisso & Pt-based CT
- Study met its co-1EPs (PK via Rybrevant blood levels) & 2EP (ORR: 30% vs 33% at 7mos. mFU), showing non-inferiority while significantly reducing administration time (~5min vs 5hrs) & lowering IRRs by 5-fold. Data was published in The JCO
Ref: Johnson | Image: Johnson
Related News:- Johnson & Johnson’s Rybrevant Plus Lazcluze Receives the CHMP’s Positive Opinion as a 1L Treatment of EGFR-Mutated NSCLC
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