J&J wins FDA approval for first subcutaneous therapy for EGFR mutated lung cancer

Johnson & Johnson has received U.S. Food and Drug Administration approval for RYBREVANT FASPRO, a subcutaneous version of amivantamab co formulated with hyaluronidase lpuj, for treatment of patients with epidermal growth factor receptor mutated locally advanced or metastatic non small cell lung cancer. Company and partner releases dated December 17 and December 18, 2025, respectively, say the approval covers the same indications previously authorized for intravenous RYBREVANT and is supported by phase 3 pharmacokinetic comparability data.

The approval stems from the phase 3 PALOMA 3 study, which Halozyme Therapeutics and Johnson & Johnson cite as demonstrating that the subcutaneous formulation met co primary pharmacokinetic endpoints. The trial measured amivantamab exposure by trough concentration on cycle 2 day 1 and by area under the curve for cycle 2 days 1 to 15, and reported results consistent with the intravenous product. A peer reviewed account of the trial appears in the Journal of Clinical Oncology, Leighl and colleagues J Clin Oncol 2024;42(30):3593 to 3605. doi:10.1200/JCO.24.01001.

Halozyme, whose ENHANZE technology enables subcutaneous delivery of highly concentrated biologics, confirmed December 18 that its hyaluronidase based delivery platform was used to create RYBREVANT FASPRO. Halozyme noted that its ENHANZE and Hypercon technologies have been licensed to multiple biopharma partners, and said the PALOMA 3 pharmacokinetic findings were instrumental to the approval.

In investor materials, Johnson & Johnson described RYBREVANT FASPRO as the first and only subcutaneously administered therapy for patients with EGFR mutated non small cell lung cancer. The company highlighted practical benefits for patients and clinics, noting that subcutaneous administration shortens infusion time compared with the intravenous regimen and can simplify delivery when paired with oral targeted agents. Company communications state that when combined with LAZCLUZE, the product enables the simplest, shortest administration time for a first line combination regimen.

In a statement included in Johnson & Johnson materials, Biljana Naumovic, President, Solid Tumor, Johnson & Johnson Innovative Medicine, said, “The approval of RYBREVANT FASPRO is a pivotal step forward, as EGFR+ NSCLC patients have previously faced limited treatment options. Now, patients are gaining greater access to this transformative treatment, as well as the tools needed to proactively manage common dermatological effects.”

Regulatory documents and the FDA approval letter itself were referenced in the company and partner press releases dated December 17 and December 18, 2025. Industry observers say the subcutaneous option could reduce chair time in oncology clinics, ease scheduling pressures, and broaden access for patients who have difficulty with prolonged intravenous infusions. Clinicians will be watching real world adoption, tolerability outside trial settings, and how the new formulation is integrated into existing EGFR targeted treatment sequences.