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# FDA OKs Subcutaneous Version of J&J Lung Cancer Drug
- URL: https://www.fdaweb.com/fda-oks-subcutaneous-version-of-j-j-lung-cancer-drug/
- Published: 2025-12-18T12:00:00.000Z
- Updated: 2026-09-14T15:29:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160416

FDA has approved a new subcutaneous formulation of Johnson & Johnson’s lung cancer drug amivantamab, allowing the therapy to be administered in minutes rather than hours and expanding options for patients with EGFR-mutated non-small cell lung cancer (NSCLC). The approval of Rybrevant Faspro, a co-formulation of amivantamab with hyaluronidase, covers all previously authorized indications for intravenous Rybrevant, according to the company. When used in combination with the J&J oral EGFR inhibitor Lazcluze (lazertinib), the therapy is approved as a first-line, chemotherapy-free regimen for patients with locally advanced or metastatic EGFR-mutated NSCLC.

Amivantamab is described as a bispecific antibody targeting EGFR and MET, two pathways implicated in tumor growth and treatment resistance, according to the company. J&J says the subcutaneous formulation reduces administration time from several hours to about five minutes and significantly lowers the rate of administration-related reactions compared with intravenous delivery. In clinical studies, administration-related reactions occurred in 13% of patients receiving the subcutaneous version versus 66% of those given the IV formulation.

The approval is based on data from the Phase 3 PALOMA-3 study, which showed that the subcutaneous formulation achieved pharmacokinetic exposure comparable to intravenous amivantamab while delivering similar or improved efficacy outcomes, J&J says. Data presented at the American Society of Clinical Oncology annual meeting and published in the *Journal of Clinical Oncology* showed longer duration of response, improved progression-free survival, and higher overall survival in patients treated with the subcutaneous regimen combined with Lazcluze, it adds. At 12 months, 65% of patients receiving the subcutaneous combination were alive, compared with 51% in the intravenous arm. Median overall survival was also higher in the subcutaneous group, with a hazard ratio of 0.62.

J&J says EGFR mutations are found in roughly 10% to 15% of Western patients with NSCLC and up to half of Asian patients, and resistance to existing targeted therapies remains a major challenge. A new analysis from the company’s MARIPOSA study demonstrated that the Rybrevant/Lazcluze combination significantly reduced the development of EGFR- and MET-driven resistance compared with AstraZeneca’s Tagrisso (Osimertinib) in the first-line setting. MET amplifications occurred in 3% of patients on the combination vs 13% on Osimertinib, it says. “Notably, acquired MET amplification led to early discontinuation in 23% percent of patients on osimertinib within six months, compared with 4% on Rybrevant plus Lazcluze,” it adds.