Rybrevant FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 2, 2024.
FDA Approved: Yes (First approved May 21, 2021)
Brand name: Rybrevant
Generic name: amivantamab-vmjw
Dosage form: Injection
Company: Johnson & Johnson Innovative Medicine
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 EGFR mutated non-small cell lung cancer.
- Rybrevant is indicated:
- in combination with lazertinib 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 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
- in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
- in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with 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. - 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, venous thromboembolic events with concomitant use of lazertinib, skin reactions, eye problems, and fetal harm.
- Common adverse reactions:
- when used in combination with lazertinib include rash, nail toxicity, infusion-related reaction, musculoskeletal pain, stomatitis, edema, VTE, paresthesia, fatigue, diarrhea, constipation, COVID-19, hemorrhage, dry skin, decreased appetite, pruritus, nausea, and ocular toxicity. Common Grade 3 or 4 laboratory abnormalities include decreased albumin, decreased sodium, increased ALT, decreased potassium, decreased hemoglobin, increased AST, increased GGT, and increased magnesium.
- when used in combination with carboplatin and pemetrexed include rash, nail toxicity, infusion-related reaction, fatigue, nausea, stomatitis, constipation, edema, decreased appetite, musculoskeletal pain, vomiting, and COVID-19. Common Grade 3 or 4 laboratory abnormalities include decreased neutrophils, decreased leukocytes, decreased platelets, decreased hemoglobin, decreased potassium, decreased sodium, increased alanine aminotransferase, increased gamma glutamyl transferase, and decreased albumin.
- 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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