The U.S. Food and Drug Administration (FDA) has granted approval to RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), marking a significant advancement in the treatment of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Developed by Johnson & Johnson, this new formulation becomes the first and only subcutaneous therapy for patients with EGFR-mutated NSCLC, offering a simpler and faster administration compared with traditional intravenous options.
The approval applies across all indications previously granted to the intravenous form of RYBREVANT®, including both first-line and later-line treatments, and can be combined with LAZCLUZE® (lazertinib) for frontline therapy.
RYBREVANT FASPRO™ markedly reduces administration time, shrinking what was once several hours in a clinical chair to approximately five minutes with subcutaneous injection. This reduced treatment burden stands to benefit patients and healthcare systems alike by minimizing clinic visits and resource use.
In addition to the time savings, clinical data demonstrate about a five-fold decrease in administration-related reactions compared with intravenous delivery. It also lowers the incidence of venous thromboembolism (VTE) among patients receiving the subcutaneous formulation.
This milestone builds on earlier approvals of amivantamab and lazertinib combinations in this patient population. In 2024, the FDA approved the intravenous combination of lazertinib and amivantamab as a chemotherapy-free first-line regimen for certain patients with EGFR exon 19 and exon 21 L858R mutations. The subcutaneous formulation now provides a more patient-centered option, designed to improve convenience without sacrificing clinical effectiveness.
Healthcare experts and patient advocates welcomed the approval, highlighting the potential to transform the treatment experience for people living with advanced lung cancer. Patient comfort, reduced chair time, and expanded access to innovative therapies are among the expected benefits.
Johnson & Johnson’s announcement signals a continued push toward more accessible, less invasive cancer care, reinforcing the trend of targeted oncology therapies that not only prolong survival but also improve quality of life.
