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FDA-Approval for Bevacizumab-awwb for Treatment of Advanced Cancers

FDA-Approval for Bevacizumab-awwb for Treatment of Advanced Cancers

by Simi Paknikar on Sep 18 2017 4:10 PM
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Highlights:

  • Bevacizumab-awwb, a biosimilar to the monoclonal antibody bevacizumab, received FDA-Approval for several advanced cancers
  • Bevacizumab-awwb is a monoclonal antibody that prevents the growth of blood vessels
  • Its introduction in the market as a competition to bevacizumab could bring down the cost of treatment, thus benefiting patients.
Bevacizumab-awwb has received US FDA approval for the treatment of several cancers. The introduction of a competitor to bevacizumab could possibly help to reduce cost of treatment and increase the availability of the medication, thus ensuring that more patients experience the benefits of the treatment.
Bevacizumab-awwb has been approved for the treatment a wide variety of advanced cancers in adult patients, which include:
  • Metastatic colorectal cancer, which is a late-stage cancer of the large intestine or rectum. ‘Metastatic’ refers to cancer that has spread to other sites. When used for this purpose, bevacizumab-awwb should be used in combination with chemotherapy that includes:
    • Intravenous 5-fluorouracil as a first- or second-line treatment or
    • Fluoropyrimidine and irinotecan or oxaliplatin as second-line treatment in patients who had progressed despite earlier treatment with a bevacizumab product-containing regimen.
It should not be used to improve outcomes in patients who have undergone resection of colorectal cancer.

  • Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer as a first option along with the anticancer drugs carboplatin and paclitaxel. Most lung cancers are non-small cell lung cancers. The non-squamous cell type include the subtypes beside the squamous cell subtype, like adenocarcinoma and large cell carcinoma
  • Glioblastoma, a type of brain cancer, which has progressed despite earlier treatment. Glioblastoma arises from astrocytes, the cells that form the supportive tissue of the brain
  • Persistent, recurrent, or metastatic cervical cancer, along with paclitaxel and cisplatin or paclitaxel and topotecan

    • Bevacizumab-awwb, however, should not be used as a substitute for bevacizumab.

      The side effects caused by bevacizumab-awwb range from mild to severe. The common adverse effects that may be expected from the treatment, include bleeds from the nose or rectum or other organs which can be severe, high blood pressure, tearing of eyes and running of nose, loss of protein through the urine, a skin condition called exfoliative dermatitis, headache, alteration in taste and back pain. In addition, it has also been associated with perforation of an organ, blood clot formation in the arteries or veins, a brain condition called posterior reversible encephalopathy syndrome, ovarian failure, and infusion-related reactions. Problems with wound healing following surgery could occur, and therefore bevacizumab-awwb should not be taken around a month before and after surgery. It should not be administered to pregnant women.

      About Bevacizumab

      Bevacizumab is a monoclonal antibody, classified as a vascular endothelial growth factor (VEGF) inhibitor. It prevents the development of blood vessels in cancer and slows its growth. It has several off-label uses that include age-related macular degeneration, metastatic breast cancer, recurrent endometrial cancer and hereditary hemorrhagic telangiectasia. Products like bevacizumab are classified as biologicals since they are obtained from a living organism.

      Reference:

      1. FDA approves first biosimilar for the treatment of cancer - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576112.htm)

      Source-Medindia


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