Rybrevant FDA Approval History
Last updated by Judith Stewart, BPharm on March 5, 2024.
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 used for the treatment of non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
- Rybrevant is indicated:
- in combination with carboplatin and pemetrexed for the first-line 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.
- as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. - 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. 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 adverse reactions when used in combination with carboplatin and pemetrexed include rash, nail toxicity, stomatitis, infusion-related reaction, fatigue, edema, constipation, decreased appetite, nausea, COVID-19, diarrhea, and vomiting. Common Grade 3 or 4 laboratory abnormalities include decreased albumin, increased alanine aminotransferase, increased gamma-glutamyl transferase, decreased sodium, decreased potassium, decreased magnesium, and decreases in white blood cells, hemoglobin, neutrophils, platelets, and lymphocytes.
- Common adverse reactions when used as a single agent include include rash, IRR, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation, and vomiting. Common Grade 3 or 4 laboratory abnormalities include decreased lymphocytes, decreased albumin, decreased phosphate, decreased potassium, increased alkaline phosphatase, increased glucose, increased gamma-glutamyl transferase, and decreased sodium.
Development timeline for Rybrevant
Further information
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