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 CT
- Study met its co-1EPs (PK via Rybrevant blood levels) plus showed improved PFS, higher mOS, longer DoR & OS, with 65% vs 51% pts alive at 12mos.; Rybrevant Faspro also reduced administration time to ~5min & lowered ARRs by 5-fold (13% vs 66%). Data was presented at ASCO 2024 & published in The JCO
Ref: J&J | Image: J&J |Press Release
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