Johnson & Johnson Receives the US FDA Approval for Rybrevant Faspro to Treat EGFR-Mutated NSCLC

Shots: FDA has approved J&J’s Rybrevant Faspro (amivantamab & hyaluronidase-lpuj, SC) for the treatment of pts with EGFRm NSCLC, covering all approved indications of Rybrevant Approval was backed by P-III (PALOMA-3) trial, evaluating SC vs IV RoA of Rybrevant, in combination with Lazcluze in advanced or metastatic EGFRm NSCLC pts (n=418) whose disease progressed on Tagrisso & Pt-based…

ByRidhi RastogiDecember 18, 2025

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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…

ByRidhi RastogiApril 9, 2025

Johnson & Johnson Receives the US FDA Approval for Rybrevant Faspro to Treat EGFR-Mutated NSCLC

Johnson & Johnson Receives the EC’s Approval for SC Rybrevant to Treat Advanced EGFR-Mutated NSCLC

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