Johnson & Johnson announces FDA approved Rybrevant in NSCLC patients

Johnson & Johnson “announced that the FDA approved RYBREVANT FASPRO, amivantamab and hyaluronidase-lpuj, the first and only subcutaneously administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer. RYBREVANT FASPRO is approved across all indications of RYBREVANT(R) (amivantamab-vmjw). Based on the results from the Phase 3 PALOMA-3 study, RYBREVANT FASPRO(TM) delivered consistent results to RYBREVANT(R), meeting both co-primary pharmacokinetic (PK) endpoints as measured by amivantamab levels in the blood (Ctrough on Cycle (C) 2 Day (D) 1 or C4D1 and C2 area under the curve. Results from PALOMA-3 were first presented as a late-breaking oral presentation at the 2024 American Society of Clinical Oncology Annual Meeting and published in the Journal of Clinical Oncology.”