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Avastin (bevacizumab) FDA approval for brain cancer treatment in US

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Wednesday, May 6, 2009, 12:23 This news item was posted in Legal category and has 0 Comments so far.


Avastin to treat most deadly form of brain cancer gets quick approval in US

Avastin, which is already used to treat lung, colon and breast cancers, has an annual global sales $4.6 billion.

Avastin (bevacizumab) received speedier approval to treat the most deadly form of brain cancer from USFDA.

Avastin (bevacizumab) is produced by Genentech, Inc which was recently acquired by Roche. Data for Avastin showed enough promise to be considered for quick approval for patients with an especially aggressive tumor, glioblastoma multiforme, a U.S. advisory panel said.

Avastin was granted approval to treat glioblastoma (brain cancer) under the FDA’s accelerated approval programme that allows provisional approval of medicines for cancer or other life-threatening diseases.

“People with this type of brain cancer have had no new treatments in more than a decade,” said Timothy Cloughesy, M.D., director, Neuro-Oncology Program of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles. “After so many years with little progress in this field, Avastin was associated with a durable tumour response and doctors now have a new medicine to offer patients.”

Avastin (bevacizumab) is produced by Genentech, Inc which was recently acquired by Roche.

A global Phase III trial in patients with newly diagnosed glioblastoma will soon begin enrollment to further evaluate Avastin in this setting, Genentech officials said.

Avastin was studied in an open-label, multicenter, non-comparative Phase II study that included 167 patients with glioblastoma that had progressed following initial treatment with temozolomide and radiation.

Patients were grouped into two arms: Avastin alone or Avastin in combination with irinotecan. A primary endpoint of the study was objective response rate. Response was assessed by magnetic resonance imaging (MRI) and measured using World Health Organization radiographic criteria along with decreased or stable corticosteroid use. MRI does not necessarily distinguish between the tumor, swelling (edema), or tissue death (necrosis) caused by prior radiation therapy.

The median age of the patients treated with Avastin alone was 54 years. Additionally, 32 percent were female, 81 percent were in first relapse, 45 percent had a Karnofsky performance status (KPS) of 90 to 100 and 55 percent had a KPS of 70 to 80. Patients with active brain hemorrhage were excluded from the study.

Tumor responses were observed in 26 percent (95% confidence interval: 17.0%, 36.1%) of the 85 patients treated with Avastin alone, and the median duration of response in these patients was 4.2 months (95% confidence interval: 3.0 months, 5.7 months), according to an FDA analysis of the study.

Avastin’s efficacy in glioblastoma is supported by another study that used the same response assessment criteria. In this single-arm study, 56 patients were treated with Avastin alone. Responses were observed in 20 percent of patients (95% confidence interval: 10.9%, 31.3%), and the median duration of response was 3.9 months (95% confidence interval: 2.4 months, 17.4 months).

Avastin side-effects

Avastin was found rater safe in patients studied. Avastin was discontinued due to adverse events in 5 percent of patients. The most frequently reported adverse events were infection (55 percent), fatigue (45 percent), headache (37 percent), high blood pressure (30 percent), diarrhea (21 percent) and nose bleeds (19 percent).

Avastin is a biologic antibody designed to specifically inhibit the vascular endothelial growth factor (VEGF). VEGF is a protein that plays an important role in the development and maintenance of blood vessels, a process known as angiogenesis. Glioblastomas express high levels of VEGF and develop an extensive network of tumor blood vessels. VEGF is a potent activator of angiogenesis throughout the lifecycle of a tumor and is thought to be critical to a tumor’s ability to grow and spread in the body.

Avastin is already used to treat lung, colon and breast cancers, and annual global sales have soared to 5.2 billion Swiss francs ($4.61 billion).

Avastin was the first anti-angiogenesis therapy approved by the FDA and is now approved for the treatment of four tumor types. Currently, Avastin is indicated for the first- and second-line treatment of metastatic colorectal cancer (mCRC) in combination with intravenous 5-FU-based chemotherapy; for the first-line treatment of unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel; and for previously untreated, metastatic or locally recurrent HER2-negative breast cancer in combination with paclitaxel. The effectiveness of Avastin in metastatic breast cancer is based on an improvement in progression-free survival. Avastin is not indicated for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Avastin in breast cancer.

Some patients treated with Avastin experienced serious side effects, including GI perforation, which is the development of a hole in the stomach, small intestine, or large intestine. In clinical trials, this side effect occurred in 0.3 to 2.4 percent of patients and in some cases resulted in fatality. Avastin therapy should be permanently stopped in people with GI perforation.Avastin treatment with Avastin can lead to slow or incomplete wound healing, severe bleeding etc.

Glioblastoma affects approximately 10,000 people per year in the United States and glioblastoma tumors nearly always return following initial treatment.

Currently, Avastin is sold at price of about $50,000 per patient per year.

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a wholly-owned member of the Roche Group, has headquarters in South San Francisco, California.

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