FDA Approves Subcutaneous Rybrevant Faspro for EGFR-Mutated Non-Small Cell Lung Cancer

TUESDAY, Dec. 23, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as the first and only subcutaneously administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).Rybrevant Faspro is approved across all indications of intravenously administered Rybrevant (amivantamab-vmjw). The subcutaneous administration is more convenient for patients and lowers the burden on health care resources. Administration time is reduced from several hours to five minutes.The approval is based on results from the phase 3 PALOMA-3 study, in which Rybrevant Faspro delivered results consistent with Rybrevant, meeting both coprimary pharmacokinetic end points, as measured by blood levels of amivantamab. Additionally, the subcutaneous administration was associated with about a fivefold reduction in administration-related reactions (13 percent versus 66 percent with intravenous administration), as well as lower incidence of venous thromboembolism (11 percent versus 18 percent with intravenous administration)."Patients now have a simple, chemotherapy-free frontline option that not only targets the disease more precisely but also significantly improves survival," Joelle Fathi, D.N.P., chief health care delivery officer at GO2 for Lung Cancer, said in a statement. "With the introduction of Rybrevant Faspro, care becomes faster, less invasive, and more aligned with what matters most to patients: time, comfort, and dignity. This therapy reduces the physical and emotional burden of lengthy infusions, giving patients and their families the opportunity to reclaim precious moments and focus on living, rather than treatment."Approval of Rybrevant Faspro was granted to Johnson & Johnson.More Information.Sign up for our weekly HealthDay newsletter

FDA Approves Subcutaneous Rybrevant Faspro for EGFR-Mutated Non-Small Cell Lung Cancer

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