Rybrevant FDA Approval History
Last updated by Judith Stewart, BPharm on June 2, 2021.
FDA Approved: Yes (First approved May 21, 2021)
Brand name: Rybrevant
Generic name: amivantamab-vmjw
Dosage form: Injection
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Non-Small Cell Lung Cancer
Rybrevant (amivantamab-vmjw) is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.
- Rybrevant is for use in patients whose disease has progressed on or after platinum-based chemotherapy.
- Rybrevant is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
- The Guardant360® CDx liquid biopsy blood test is used as a companion diagnostic with Rybrevant to identify patients with EGFR exon 20 insertion mutations.
- Rybrevant is administered via intravenous infusion weekly for four weeks (the first dose is a split infusion over two consecutive days), then every two weeks. Premedication with antihistamines, antipyretics and glucocorticoids is recommended to reduce the risk of infusion-related reactions.
- Rybrevant may cause serious side effects including infusion-related reactions (IRR), interstitial lung disease/pneumonitis, skin reactions, and eye problems. Common side effects include rash, IRR, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation, vomiting, and laboratory abnormalities.
Development Timeline for Rybrevant
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.