Posted from: Tuesday, January 16, 2018 - 01:24 PM - Present

Avastin Receives Full Approval to Treat Glioblastoma

December 5, 2017 – The U.S. FDA has granted full approval for Avastin® (bevacizumab), manufactured by Genentech, to treat recurring glioblastoma in adult patients. The drug originally received accelerated approval under this indication in 2009, with full approval made contingent upon the results of a then-ongoing clinical trial.

Glioblastoma is one of the most common forms of brain cancer in the United States, and is diagnosed in an estimated 12,300 U.S. patients annually. In the completed clinical trial, Avastin was shown to improve progression-free survival rates (4.2 months) for patients taking the drug in combination with lomustine, compared to patients who took lomustine alone (1.5 months). A monoclonal antibody, Avastin specifically inhibits vascular endothelial growth factor (VEGF), which may help prevent the growth of blood vessels that contribute to tumor growth. Recommended dosing is based on indication.

In addition to glioblastoma, Avastin is approved to treat other forms of cancer, including metastatic colorectal cancer, metastatic non-squamous non-small cell lung cancer, metastatic renal cell carcinoma, and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. The drug carries a black box warning that cautions patients of the potential for gastrointestinal perforations, surgery and wound healing complications, and severe or fatal hemorrhage. Avastin should not be given sooner than 28 days following major surgery, or before a surgical wound has fully healed.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

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Last Updated Friday, September 21, 2018 - 10:23 PM.