In what cases is bevacizumab (avastin) currently used to treat brain cancer and how successful has it been so far?
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Expert AnswersDavidReardonMD (Physician - Oncology - Hematology/Oncology (Verified) ) - 07 / 08 / 2012
Bevacizumab is the prototype of anti-angiogenic agents, a class of anti-cancer therapeutics that are designed to inhibit blood vessel formation by tumors. Bevacizumab specifically blocks the primary factor secreted by tumor cells that drives new blood vessel formation called vascular endothelial growth factor or VEGF. The exact mechanism of how bevacizumab helps to kill cancer cells is not clear, but laboratory research demonstrates that bevacizumab blocks the ability of tumors to generate new blood vessels that are otherwise required to provide nutrition and oxygen to the cancer. Without these new blood vessels tumors are less likely to grow and more likely to die.
Bevacizumab received accelerated approval by the US Food and Drug Administration for recurrent glioblastoma in May, 2009. This approval was based on a review of two clinical trials which showed that bevacizumab therapy increased the rate of radiographic responses (i.e. shrinkage of the tumor on MRI or CT scan) compared to previously existing data from other treatments. Importantly, many of the patients who achieved radiographic responses were able to maintain them for a prolonged period of time. Health Canada and regulatory health agencies of many countries also approved bevacizumab for recurrent glioblastoma based on these data. In contrast, the European Medicinal Agency did not grant approval, primarily because due to the lack of adequate control groups in these two studies. Two very large placebo-controlled phase III studies comparing standard radiation and temozolomide with either placebo or bevacizumab for newly diagnosed glioblastoma patients recently completed accrual and preliminary results from these studies are expected in the next 6-12 months. If these studies are positive, bevacizumab is expected to be fully approved by the US FDA and will likely be fully approved and therefore available for newly diagnosed glioblastoma patients elsewhere in the world.
Preliminary studies have shown encouraging outcome with bevacizumab among patients with recurrent grade III malignant glioma tumors (such as anaplastic astrocytoma, anaplastic oligodendroglioma and anaplastic oligoastrocytoma), recurrent and progressive meningiomas and for patients with radiation necrosis of the brain. However, bevacizumab is not approved for patients with these conditions because definitive clinical trials for these indications have not been performed.
Bevacizumab received accelerated approval by the US Food and Drug Administration for recurrent glioblastoma in May, 2009. This approval was based on a review of two clinical trials which showed that bevacizumab therapy increased the rate of radiographic responses (i.e. shrinkage of the tumor on MRI or CT scan) compared to previously existing data from other treatments. Importantly, many of the patients who achieved radiographic responses were able to maintain them for a prolonged period of time. Health Canada and regulatory health agencies of many countries also approved bevacizumab for recurrent glioblastoma based on these data. In contrast, the European Medicinal Agency did not grant approval, primarily because due to the lack of adequate control groups in these two studies. Two very large placebo-controlled phase III studies comparing standard radiation and temozolomide with either placebo or bevacizumab for newly diagnosed glioblastoma patients recently completed accrual and preliminary results from these studies are expected in the next 6-12 months. If these studies are positive, bevacizumab is expected to be fully approved by the US FDA and will likely be fully approved and therefore available for newly diagnosed glioblastoma patients elsewhere in the world.
Preliminary studies have shown encouraging outcome with bevacizumab among patients with recurrent grade III malignant glioma tumors (such as anaplastic astrocytoma, anaplastic oligodendroglioma and anaplastic oligoastrocytoma), recurrent and progressive meningiomas and for patients with radiation necrosis of the brain. However, bevacizumab is not approved for patients with these conditions because definitive clinical trials for these indications have not been performed.
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