Genentech has presented further submission to the FDA for Avastin in combination with chemotherapy commonly used in women with advanced breast cancer

Avastin may impair fertility. Patients who are pregnant or planning to become pregnant should discuss with your doctor about the potential risk of pregnancy loss or the potential risk of Avastin to the fetus during and after treatment with Avastin and the need to pursue effective for at least six months after the last dose of Avastin.- AVADO: Avastin and chemotherapy with docetaxel compared to docetaxel chemotherapy alone

Gastrointestinal perforation: Treatment with Avastin can lead to the development of a potentially serious side effect called GI perforation, which is the development of a hole in the stomach, small intestine or large intestine. In clinical trials, this event occurred more than those who received bevacizumab compared to the comparison group . In some cases, gastrointestinal perforation leads to the inevitable.

People treated with Avastin may experience side effects. In clinical trials, some patients were treated with Avastin experienced serious and sometimes fatal side effects, including:

- TAPE 1: Avastin is a taxane, anthracycline-based or capecitabine chemotherapy compared to chemotherapy alone

Genentech is committed to understanding the potential role of Avastin in breast cancer and present data separately from the other three FDA randomized phase III Avastin in the treatment of this disease when it is available, including two recently announced TAPE study in patients previously treated chemotherapy for metastatic HER2-negative breast cancer.

The density of the reaction chambers obtained from the platform based on more traditional than the digital valve PCR techniques by a factor of 100, translating directly into improved performance.

Avastin was evaluated in three different international, multicenter, randomized phase III trial of women who have not previously received treatment for advanced HER2-negative breast cancer .

- E2100: Avastin and paclitaxel compared to paclitaxel chemotherapy alone

Avastin is a solution for intravenous infusion, and is a biologic antibody designed to bind specifically to a protein called vascular endothelial growth factor . VEGF plays an important role throughout the life cycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin interferes with the blood supply of tumors directly binding to the VEGF protein to prevent interactions with receptors on the cells of blood vessels. Avastin does not bind to receptors on normal cells or tumor. The blood supply of tumors is thought to be central to the ability of a tumor to grow and spread in the body . For more information about angiogenesis, visit the site

Common side effects that occurred in more than 10 % of those who received Avastin for several types of cancer, and at least twice the rate in the control group were nose bleeds, high blood pressure, inflammation of the nose, too protein in the urine, taste alteration, dry skin, rectal bleeding, tear production disorder, and inflammation of the skin . In all studies, treatment with Avastin was aimed at 8.4 per cent to 21 per cent of people because of side effects.

Avastin is currently approved in combination with paclitaxel chemotherapy for first-line treatment of HER2-negative advanced breast cancer. The approval is based on the results of the Phase III E2100 and granted under the FDA’s accelerated approval that allows provisional approval of medicines or other deadly diseases. Currently, the effectiveness of Avastin in metastatic breast cancer is based on an improvement in progression-free survival. No data are available that demonstrate an improvement in disease-related symptoms or increased survival with Avastin in breast cancer.

Severe bleeding: Treatment with Avastin can lead to serious bleeding, including coughing up blood, bleeding in the stomach, vomiting of blood, brain hemorrhages, nosebleeds and vaginal bleeding. Several types of cancer, 1.2 % to 4.6 % of those who received Avastin experienced serious bleeding from fatal. People who have recently coughed up blood or severe bleeding should not receive Avastin. Treatment with Avastin should be permanently discontinued if serious bleeding occurs .

In Study E2100 metastatic breast cancer, there was an increase of 20.5 per cent in serious side effects in life-threatening and fatal for Avastin and paclitaxel vs. paclitaxel chemotherapy alone. Because mild side effects of Avastin and Taxol have not been studied, are not known. Serious life-threatening side effects that increased by 2 % or more of people who received Avastin plus paclitaxel were numbness and tingling in the fingers and toes , high blood pressure , , infection without any reduction in white blood cells , white blood cells that contain harmful bacteria , vomiting , , bone pain , headache , nausea , stroke , , infection , rash and too much protein in urine . 18 per %), hypertension and fatigue . Failure has been observed in people who received Avastin plus paclitaxel vs. paclitaxel alone . Among those receiving anthracyclines, congestive heart failure was more common in people who received Avastin plus paclitaxel vs. paclitaxel alone . Deaths due to side effects were observed in 1.7 % of those who received bevacizumab plus paclitaxel. Causes of death were the development of a hole in the stomach, small intestine or large intestine , and diarrhea / abdominal pain / weakness / low blood pressure .

Genentech, Inc., a full member of the Roche Group , announced today that the company has filed two additional Biologics License to the Food and Drug Administration for Avastin to treat women who have not received chemotherapy for advanced HER2-negative . The other is based on the phase III RIBBON 1, which investigated Avastin in combination with, anthracycline-taxane-based chemotherapy or capecitabine.

Both studies met their primary endpoint of improving the time women lived without their disease getting worse .

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