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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

May 21, 2021Approval FDA Approves Rybrevant (amivantamab-vmjw) as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Jan 29, 2021New Amivantamab Data from CHRYSALIS Study Show Robust Clinical Activity and Durable Responses in Patients with Metastatic or Unresectable Non-Small Cell Lung Cancer and EGFR Exon 20 Insertion Mutations
Dec  3, 2020Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
May 18, 2020Janssen Announces Phase 1 Results for Bispecific Antibody Amivantamab in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer Harboring Exon 20 Insertion Mutations

Further information

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