Rybrevant Faspro gains new indication
Johnson & Johnson’s Rybrevant Faspro (amivantamab + hyaluronidase) received an FDA nod as a once‑monthly EGFR‑targeted therapy, marking a differentiated dosing profile in a crowded lung‑cancer space reported. That dosing convenience could change treatment patterns and formulary discussions for oncology device and drug combinations.
The [FDA approved]fda.gov Rybrevant Faspro for subcutaneous injection on December 17, 2025, authorizing the new formulation across the same indications as intravenous Rybrevant. The PALOMA‑3 [trial randomized]fda.gov 418 patients and reported systemic administration‑related reactions of 13% with subcutaneous Rybrevant Faspro versus 66% infusion‑related reactions with IV amivantamab. Johnson & [Johnson announced]jnj.com on February 17, 2026 that the FDA cleared a simplified once‑monthly dosing schedule for Rybrevant Faspro when given with oral LAZCLUZE (lazertinib) in first‑line EGFR‑mutated advanced NSCLC. The [company said]jnj.com patients may transition to the monthly regimen as early as Week 5 under the new labeling. Final MARIPOSA [data showed]jnj.com amivantamab plus lazertinib produced a statistically significant overall‑survival benefit versus osimertinib in Asian patients, with median overall survival not reached and projected to exceed four years. PALOMA‑3 [also demonstrated]ascopubs.org pharmacokinetic noninferiority for subcutaneous versus IV amivantamab in randomized comparison with IV dosing. Regulatory filings and presentations report Day‑1 median time‑in‑chair dropping from about 6.5 hours with IV administration to roughly 23 minutes with the subcutaneous formulation, and single‑injection administration times of approximately five minutes.oncodaily.com Rybrevant Faspro is co‑formulated with recombinant human hyaluronidase rHuPH20 (Halozyme ENHANZE® technology), per the company release and product information.prnewswire.com
