Bevacizumab-awwb (Mvasi)

Note: this is the first FDA-approved biosimilar. The information below is reproduced from the Bevacizumab (Avastin) page, except for the details of FDA indication.

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.
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.

Diseases for which it is used

• Carcinoma of unknown primary
• Anaplastic glioma
• Breast cancer
• Cervical cancer
• Cholangiocarcinoma
• Colorectal cancer
• Esophageal cancer
• Follicular lymphoma
• Glioblastoma
• Hepatocellular carcinoma
• Melanoma
• Malignant pleural mesothelioma
• Neuroendocrine tumor
• Non-small cell lung cancer
• Ovarian cancer
• Pancreatic NET
• Renal cell carcinoma
• Small cell lung cancer
• Soft tissue sarcoma
• Testicular cancer
• Endometrial cancer
• Vascular sarcoma

History of changes in FDA indication

• 2017-09-14: Approved for the treatment of patients with metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment.
  • Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
• 2017-09-14: Approved for the treatment of patients with metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrmidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen.
• 2017-09-14: Approved for the treatment of patients with non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease. (Based on MAPLE)
• 2017-09-14: Approved for the treatment of patients with glioblastoma with progressive disease following prior therapy, based on improvement in objective response rate. No data available demonstrating improvement in disease-related symptoms or survival with bevacizumab products.
• 2017-09-14: Approved for the treatment of patients with metastatic renal cell carcinoma, in combination with interferon alfa.
• 2017-09-14: Approved for the treatment of patients with cervical cancer that is persistent, recurrent, or metastatic disease, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
• Note: Bevacizumab (Avastin) has a label for ovarian cancer, which was not included in the initial FDA approval for bevacizumab-awwb.

Also known as

• Code name: ABP-215
• Brand name: Mvasi

References

1. MAPLE: Thatcher N, Goldschmidt JH, Thomas M, Schenker M, Pan Z, Paz-Ares Rodriguez L, Breder V, Ostoros G, Hanes V. Efficacy and Safety of the Biosimilar ABP 215 Compared with Bevacizumab in Patients with Advanced Nonsquamous Non-small Cell Lung Cancer (MAPLE): A Randomized, Double-blind, Phase III Study. Clin Cancer Res. 2019 Apr 1;25(7):2088-2095. Epub 2019 Jan 7. Erratum in: Clin Cancer Res. 2019 May 15;25(10):3193. link to original article PubMed NCT01966003