Bevacizumab (Avastin)

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General information

Class/mechanism: Monoclonal antibody that inhibits angiogenesis by binding VEGF and preventing the interaction of VEGF with its receptors (Flt-1 and KDR) on the surface of endothelial cells.[1][2][3]
Route: IV
Extravasation: neutral

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, Medscape,UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is established (work in progress)

Diseases for which it is used

Information about counterfeit bevacizumab

Patient drug information

History of changes in FDA indication

Breast cancer - WITHDRAWN

  • 2/22/2008: Granted accelerated approval for use in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2 negative breast cancer. (New disease entity; based on ECOG E2100)
    • 11/18/2011: Approval for metastatic HER2 negative breast cancer withdrawn. (Based on AVADO & RIBBON-1)
      • Note: this withdrawal is considered to be controversial, and the breast cancer indication remains in the EMA approval. This article provides a good overview.

Cervical cancer

Colorectal cancer

  • 2/26/2004: Initial FDA approval, in combination with intravenous 5-fluorouracil–based chemotherapy...for first- line treatment of patients with metastatic carcinoma of the colon or rectum. (Based on AVF2107g)
  • 6/20/2006: Approved for second-line treatment of metastatic carcinoma of the colon or rectum. (New treatment setting without explicit requirement for combination therapy; based on ECOG E3200 & TRC-301)
  • 1/23/2013: Approved for use in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed on a first-line bevacizumab-containing regimen. (Based on ML18147)
  • Metastatic colorectal cancer, with intravenous 5-fluorouracil–based chemotherapy for first- or second-line treatment.
  • Limitation: Lack of efficacy in adjuvant treatment of colon cancer. (Based on AVANT & NSABP C-08)

Glioblastoma

  • 5/5/2009: Granted accelerated approval as a single agent for patients with glioblastoma, with progressive disease following prior therapy. (Based on NCI 06-C-0064E & AVF3708g)
  • 12/5/2017: Converted to regular approval for patients with glioblastoma with progressive disease following prior therapy. (Based on EORTC 26101)

Hepatocellular carcinoma

  • 5/29/2020: Approved in combination with atezolizumab for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. (Based on IMbrave150)

Non-small cell lung cancer, nonsquamous

Ovarian cancer

Renal cell carcinoma

  • 7/31/2009: Approved in combination with interferon alfa for the treatment of patients with metastatic renal cell carcinoma. (Based on AVOREN)

History of changes in EMA indication

  • 1/12/2005: Initial market authorization as Avastin.

Also known as

  • Generic name: rhuMab-VEGF
  • Brand names: Altuzan, Avastin, BevaciRel, Bevarest

References