J&J’s Rybrevant Faspro gains FDA approval for new dosing in NSCLC

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Source: Pharmaceutical Technology

Original: https://www.pharmaceutical-technology.com/news/jjs-rybrevant-faspro-fda-approval...

Published: Wed, 18 Feb 2026 09:37:01 +0000

Johnson & Johnson received US Food and Drug Administration (FDA) approval for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), the first and only subcutaneous treatment for patients with EGFR-mutated NSCLC[1][2]. The FDA approval was issued on December 17, 2025 and covers all indications of the original intravenous drug Rybrevant[1]. The subcutaneous form allows for faster administration compared to long-term intravenous infusion and provides patients with a more convenient method of treatment[4]. The approval is based on the results of the PALOMA-3 study, which compared subcutaneous amivantamab with intravenous lazertinib in 418 patients with advanced EGFR-mutated NSCLC[6]. Combination therapy with Rybrevant plus Lazcluze (lasertinib) demonstrated a statistically significant reduction in the risk of death compared to osimertinib in the MARIPOSA study (hazard ratio 0.75; 95% confidence interval 0.61-0.92)[1]. The subcutaneous form has a lower rate of side effects—only 13 percent compared to 66 percent for the intravenous form[1].