FDA Approves RYBREVANT FASPRO™ A First-of-its-Kind Subcutaneous Therapy for Lung Cancer

The U.S. Food and Drug Administration (FDA) has officially approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), a milestone development in the treatment of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Developed by Johnson & Johnson, this is the world’s first and only subcutaneous therapy for this patient population.

This approval is designed to replace the time-intensive intravenous (IV) infusions of the original RYBREVANT® with a rapid, patient-friendly injection that delivers the same clinical efficacy in a fraction of the time.

Key Clinical Benefits: Time, Safety, and Survival

The approval is backed by the Phase 3 PALOMA-3 trial, which highlighted several game-changing improvements over the traditional IV delivery:

Drastic Time Savings: Administration time has been cut from several hours (median of 5 hours) to approximately five minutes.
Fewer Side Effects: The study showed a five-fold reduction in administration-related reactions (13% for subcutaneous vs. 66% for IV).
Improved Survival: Unexpectedly, the subcutaneous group showed improved overall survival (OS) compared to the IV group, with 65% of patients alive at 12 months versus 51% in the IV arm.
Lower Blood Clot Risk: A reduced incidence of venous thromboembolism (VTE) was observed (11% vs. 18%).

Broad Indications & First-Line Use

RYBREVANT FASPRO™ is approved for all indications previously held by the IV formulation. Most notably, it can be combined with LAZCLUZE® (lazertinib) as a chemotherapy-free, first-line treatment for patients with common EGFR mutations (Exon 19 deletions or L858R substitution).

By blocking both EGFR and MET pathways while engaging the immune system, this combination offers a powerful alternative to current standard-of-care oral inhibitors like osimertinib.

A Patient-Centered Future

For patients, this move represents more than just a medical update; it is a restoration of personal time and dignity. By reducing “chair time” in clinics, the therapy minimizes the physical and emotional burden associated with advanced cancer care.

“With the introduction of RYBREVANT FASPRO, care becomes faster, less invasive, and more aligned with what matters most to patients: time, comfort, and dignity.” — Joelle Fathi, D.N.P., Chief Healthcare Delivery Officer, GO2 for Lung Cancer.