Bevacizumab-maly (Alymsys)

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

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

• 2022-04-13: Approved for metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first or second-line treatment.
• 2022-04-13: Approved for metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
• 2022-04-13: Approved for first-line non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel.
• 2022-04-13: Approved for recurrent glioblastoma in adults.
• 2022-04-13: Approved for metastatic renal cell carcinoma in combination with interferon alfa.
• 2022-04-13: Approved for persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
• 2022-04-13: Approved for epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel.
• 2022-04-13: Alymsys is not indicated for adjuvant treatment of colon cancer.

Also known as

• Brand name: Alymsys