Johnson and Johnson’s Rybrevant Faspro combination in NSCLC approved by FDA

Johnson & Johnson (JNJ) has received approval from the FDA for Rybrevant Faspro – amivantamab and hyaluronidase-lpuj -, which is co-formulated with Halozyme Therapeutics’ (HALO) Enhanze drug delivery technology, for patients with epidermal growth factor receptor, or EGFR,-mutated locally advanced or metastatic non-small cell lung cancer – NSCLC -. Rybrevant Faspro is approved across all indications of Rybrevant and represents the first and only subcutaneously administered targeted therapy for patients with EGFR+ mNSCLC. Compared to intravenous delivery, Rybrevant Faspro significantly reduced administration time from several hours to approximately five minutes and demonstrated an approximately fivefold reduction in administration-related reactions. Based on the results from the Phase 3 PALOMA-3 study, Rybrevant Faspro delivered consistent results to Rybrevant, meeting both co-primary pharmacokinetic endpoints.