HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) has won U.S. Food and Drug Administration approval for RYBREVANT FASPRO, the first and only subcutaneous therapy for patients with EGFR-mutated non-small cell lung cancer, marking a significant shift in how a leading lung cancer treatment is delivered.
The approval allows RYBREVANT FASPRO to be used across all existing indications for RYBREVANT, replacing intravenous infusions that can take hours with a five-minute injection. The move sharply reduces treatment time and eases pressure on infusion centers while improving the patient experience.
Clinical data show the subcutaneous formulation delivers meaningful practical benefits. Compared with intravenous administration, RYBREVANT FASPRO reduced administration-related reactions to 13 percent from 66 percent and lowered the incidence of venous thromboembolism to 11 percent from 18 percent. Johnson & Johnson said the shorter administration time and improved tolerability could make treatment more accessible and less disruptive for patients and providers.
The FDA decision builds on results from the Phase 3 PALOMA-3 study, which demonstrated that the subcutaneous therapy achieved comparable drug levels in the bloodstream to the intravenous version while delivering favorable outcomes in progression-free and overall survival. Data presented at the 2024 American Society of Clinical Oncology meeting and published in the Journal of Clinical Oncology showed longer survival outcomes for patients receiving the subcutaneous regimen in combination with LAZCLUZE.
At 12 months, 65 percent of patients treated with the subcutaneous therapy were alive, compared with 51 percent receiving intravenous treatment. Median overall survival was higher in the subcutaneous arm when paired with LAZCLUZE, reinforcing the clinical impact of the new formulation.
The approval also strengthens Johnson & Johnson’s position in first-line EGFR-mutated lung cancer treatment, following previously reported Phase 3 MARIPOSA data. In that study, RYBREVANT plus LAZCLUZE significantly reduced the risk of death compared with osimertinib, with overall survival projected to exceed four years in a chemotherapy-free regimen.
Company executives and clinicians described the approval as a turning point for patients who have historically faced lengthy infusions and limited frontline options. Beyond convenience, the subcutaneous therapy maintains a safety profile consistent with intravenous delivery, with the most common side effects including rash, fatigue, musculoskeletal pain, and gastrointestinal symptoms.
For Johnson & Johnson, the FDA clearance represents both a clinical and strategic win. By pairing a differentiated delivery method with strong survival data, the company is positioning RYBREVANT FASPRO as a patient-centered advance in a highly competitive oncology market where outcomes, efficiency, and quality of life increasingly drive adoption.
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