FDA

FDA greenlights Rybrevant Faspro for all amivantamab indications

December 31, 2025

Brand name: Rybrevant Faspro

Generic name: amivantamab and hyaluronidase-lpuj

Manufacturer: Johnson & Johnson

Approval date: December 17, 2025

FDA has approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), a subcutaneously (SC) administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Rybrevant Faspro is approved across all indications of Rybrevant (amivantamab-vmjw).

According to the manufacturer, Rybrevant Faspro provides greater patient convenience and reduces healthcare burden compared to IV delivery by cutting administration time from hours to just five minutes, lowering administration-related reactions fivefold, and decreasing venous thromboembolism incidence.

Efficacy & safety

The Phase 3 PALOMA‑3 study (NCT05388669) demonstrated that SC amivantamab plus lazertinib achieved non-inferior pharmacokinetics and efficacy vs. IV administration, with comparable overall response rates (30% vs. 33%) and longer duration of response (median 11.2 vs. 8.3 months) and progression‑free survival (6.1 vs. 4.3 months). SC delivery—administered in approximately five minutes—was associated with a five‑fold reduction in infusion‑related reactions (13% vs. 66%) and significantly improved overall survival (hazard ratio, 0.62; 65% vs. 51% 12‑month survival), while maintaining a consistent safety profile.

Sources:

US FDA approval of Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) enables the simplest, shortest administration time for a first-line combination regimen when combined with Lazcluze® (lazertinib). [News release]. 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-enables-the-simplest-shortest-administration-time-for-a-first-line-combination-regimen-when-combined-with-lazcluze-lazertinib

Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) [package insert]. Johnson & Johnson. https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT+Faspro-pi.pdf Revised December 2025. Accessed December 22, 2025.