Genentech Seeks Accelerated Approval Of Avastin

Genentech Inc. is seeking accelerated FDA approval of its drug Avastin, to fight the most aggressive form of brain cancer.

Glioblastoma multiforme (grade IV astrocytoma) is an aggressive, malignant form of brain cancer with no cure and limited treatment options.

According to the National Cancer Institute about 19,000 cases of primary brain tumors - those that originate in the brain - are diagnosed every year in the U.S.

“No substantial improvements in the treatment of glioblastoma have been made in over 20 years,” said Dr. Hal Barron, Genentech’s chief medical officer. “Gliobastoma is devastating and people suffering from the disease are in desperate need of new treatment options.”

Drug companies are usually required to prove the effectiveness of a drug in three separate clinical trials. But, Genentech is seeking to have Avastin approved for brain cancer on the basis of a Phase II clinical trial (BRAIN).

The agency sometimes grants such approvals for medications to treat cancer or other life-threatening diseases if early stage trials show evidence that the drug is effective.

The study found, when Avastin was evaluated as a single agent - over six months - 43 percent of 167 glioblastoma patients, lived without their disease advancing, defined as progression-free survival (PFS). According to the company, the study found 28 percent of patients responded to Avastin and tumors decreased in size by 50 percent or more.

Using current treatment options, only 15 percent of patients live six months without their cancer progressing and less than 10 percent see a 50-percent or better decrease in the size of their tumors, Genentech said in a statement.

In early 2009, the company plans to launch a global Phase III study, in patient’s newly diagnosed with glioblastoma.

Avastin, also known as bevacizumab, was approved by the FDA in 2004, for the treatment of patients with metastatic colorectal cancer -- cancer that has spread to other parts of the body.

Avastin, a monoclonal antibody, is the first product to be approved that works by preventing the formation of new blood vessels, a process known as angiogenesis. Avastin was shown to extend patients' lives by about five months when given intravenously as a combination treatment along with standard chemotherapy drugs for colon cancer. #