Brain tumors are masses of abnormal cells that have grown out of. In most other parts of the body, it is very important to distinguish between benign (not cancer) and malignant tumors (cancer) is. Benign tumors in other parts of the body are almost never fatal. The main cause of cancer is so dangerous that they spread throughout the body.

And today there is good news for Brain tumors patients, referring to the American Cancer Society that the FDA was recently to approve Avastin (bevacizumab). The Avastin is work to treat glioblastoma multiforme (GBM) or Brain tumors. The FDA approves Avastin as the latest for the drug, which is also used to treat certain types of breast, lung, colon, and rectum cancers.

Glioblastoma is the fast-growing brain tumors that can interfere with the normal brain tissue, which can be very difficult to treat. After initial treatment with surgery, radiation and / or chemotherapy, often comes back. Genentech calls the drug the first new treatment for glioblastoma for more than a decade, says a press release.

"This type of cancer is very resistant to treatment and therefore a challenge to treat," said Richard Pazdur, MD, Head of the Office of Oncology Drugs in FDA's Center for Drug Evaluation and Research. "Avastin is a therapy for patients with progressive GBM who have not responded to other drugs.”

FDA approved Avastin for GBM under its accelerated approval process, which aims to develop drugs for life-threatening diseases early.

The approval was based on results from 2 phases II clinical studies have shown that Avastin reduced tumor size in some glioblastoma patients. The first study 167 patients divided into 2 groups: one group received Avastin only, the other a combination of Avastin and the chemotherapy drug irinotecan. Of the 85 patients treated with Avastin only 26% had their tumors shrink as a result of drugs. In the second test, which followed 56 patients treated with Avastin alone, 20% responded to the drug. In both studies, the effect lasted on average about 4 months.

The studies could not determine if the drug relieved symptoms of the disease or if it helped people live longer. Some serious side effects included bleeding / bleeding, high blood pressure, nose bleeds, blood clots in veins or arteries, a hole (holes) in the stomach or intestines and wound-healing complications. More generally, but less serious side effects included headache, irritated nose, protein in urine, taste changes, dry skin, rectal bleeding, tear production disease and inflammation of the skin.

"Today was not have been possible without the commitment of doctors, patients, the FDA, and especially those who participated in clinical trials and their families who had the courage to support them," said Hal Barron, MD, Executive Vice President, Global Development and Chief Medical Officer, Genentech, the FDA announcement was made. "A global phase III study in patients with newly diagnosed glioblastoma registration will begin evaluation of Avastin in this setting." Other studies of Avastin for the treatment of brain tumors are ongoing.

Avastin works by slowing the growth of new blood vessels. The recommended dose for the treatment of glioblastoma is 10 mg / kg IV every 2 weeks.

Genentech is also working with the FDA approval for use of drugs for the treatment of late kidney cancer.



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