Johnson & Johnson Receives the EC’s Approval for SC Rybrevant to Treat Advanced EGFR-Mutated NSCLC
Shots:
- The EC has approved 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
- Approval was backed by P-III (PALOMA-3) trial, evaluating non-inferiority of PK, safety & efficacy of 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 to ~5min & lowering IRRs by 5-fold (13% vs 66%). Data was presented at ASCO 2024 & published in The JCO
Ref: Johnson & Johnson | Image: Johnson & Johnson
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