FDA Approves First Subcutaneous Therapy for EGFR-Mutated Lung Cancer

Johnson & Johnson has secured U.S. Food and Drug Administration approval for RYBREVANT FASPRO™, marking a significant advance in the treatment of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). The newly approved formulation is the first and only subcutaneously administered therapy for this patient population and is approved across all indications currently held by intravenous RYBREVANT® (amivantamab).

The approval introduces a more convenient option for patients and healthcare providers, dramatically reducing treatment time and the burden associated with infusions. While intravenous administration of RYBREVANT can take several hours, RYBREVANT FASPRO™ is delivered in approximately five minutes. This shorter administration time is expected to ease pressure on oncology clinics and allow patients to spend less time undergoing treatment.

Clinical data show that the subcutaneous formulation also improves tolerability. In comparative studies, administration-related reactions were observed in 13 percent of patients receiving the subcutaneous therapy, compared with 66 percent in those treated intravenously. In addition, the incidence of venous thromboembolism was lower in the subcutaneous arm, further supporting the safety benefits of the new formulation.

The FDA decision was supported by results from the Phase 3 PALOMA-3 study, which demonstrated that RYBREVANT FASPRO™ achieved pharmacokinetic outcomes consistent with the intravenous version. Key measures of drug exposure in the blood met both co-primary endpoints, confirming comparable delivery of amivantamab. The findings were first presented at the 2024 American Society of Clinical Oncology Annual Meeting and later published in the Journal of Clinical Oncology.

Beyond pharmacokinetics, the PALOMA-3 data indicated meaningful clinical advantages for the subcutaneous formulation. Patients treated with RYBREVANT FASPRO™ showed longer duration of response, improved progression-free survival and extended overall survival compared with those receiving intravenous therapy. When combined with LAZCLUZE®, the subcutaneous regimen achieved a notably higher median overall survival, with 65 percent of patients alive at 12 months versus 51 percent in the intravenous arm.

Patient advocates and clinicians have welcomed the approval, highlighting the impact on quality of life. Experts note that a chemotherapy-free, subcutaneous option aligns more closely with patient priorities, reducing the physical and emotional toll of lengthy infusions while maintaining strong clinical outcomes.

The approval also builds on prior success for the RYBREVANT and LAZCLUZE combination in first-line treatment of locally advanced or metastatic EGFR-mutated NSCLC. In the Phase 3 MARIPOSA study, the combination significantly reduced the risk of death compared with osimertinib, with overall survival projected to exceed four years. Investigators say this benefit reflects a shift in disease biology by delaying resistance mechanisms without the need for chemotherapy.

Safety results for RYBREVANT FASPRO™ were largely consistent with the known profile of intravenous administration. The most common adverse reactions included rash, nail toxicity, fatigue, musculoskeletal pain and gastrointestinal effects. Importantly, interruptions due to administration-related reactions were rare with the subcutaneous formulation.

Johnson & Johnson said the approval expands access to a transformative therapy for patients with EGFR-positive NSCLC and reinforces its commitment to patient-centered innovation. By combining strong survival data with faster, less invasive delivery, RYBREVANT FASPRO™ is positioned to redefine standards of care in this hard-to-treat form of lung cancer.