US EditionFDA Approves First Subcutaneous Drug for EGFR-Mutated Non-Small Cell Lung Cancer
RYBREVANT FASPRO offers a five-minute subcutaneous treatment with 13% administration reactions versus 66% for IV, improving convenience and reducing venous thromboembolism risks.
- Yesterday, Dec. 17, 2025, Johnson & Johnson announced that the U.S. Food and Drug Administration approved RYBREVANT FASPRO, the first subcutaneously administered therapy for EGFR‑mutated non‑small cell lung cancer.
- The approval follows Phase 3 MARIPOSA and PALOMA‑3 results, with MARIPOSA and PALOMA‑3 showing improved survival and reduced resistance for RYBREVANT plus LAZCLUZE.
- Clinical PK data from PALOMA‑3 showed consistency with IV delivery, and SC administration reduced administration‑related reactions to 13 percent versus 66 percent with IV, while prophylactic anticoagulation normalized VTE rates.
- Joelle Fathi, D.N.P., said `Patients now have a simple, chemotherapy-free frontline option that not only targets the disease more precisely but also significantly improves survival` and Johnson & Johnson provides RYBREVANT withMe patient support for cost navigation and care.
- Amid safety trade‑offs, clinicians should use prophylactic anticoagulation to manage VTE risk and monitor for VTE and ILD/pneumonitis, withholding therapy if needed.
51 Articles
51 Articles
FDA approves first subcutaneous drug for EGFR-mutated non-small cell lung cancer
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).
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U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Enables the Simplest, Shortest Administration Time for a First-Line Combination Regimen when Combined with LAZCLUZE® (lazertinib)
RYBREVANT FASPRO™, the first and only subcutaneous therapy for patients with EGFR-mutated NSCLC, reduces administration time from hours to minutes and significantly reduces administration-related reactions1-5
FDA Approves Rybrevant Faspro for EGFR-Mutated Non-Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has granted […] The post FDA Approves Rybrevant Faspro for EGFR-Mutated Non-Small Cell Lung Cancer first appeared on GeneOnline News. The post FDA Approves Rybrevant Faspro for EGFR-Mutated Non-Small Cell Lung Cancer appeared first on GeneOnline News.
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