Authorization of Roche’s Avastatin Revoked As Treatment for Breast Cancer

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Breast cancer is still considered as the most common type of malignancy found among the female population in United States. Thus, many researchers and medical health professionals are still continuing to conduct thorough and extensive studies and researches in order to determine the major risk or cause of breast cancer which can predispose women to the said disease. Also, part of the studies conducted is the researches about various treatments which can actually cure and treat breast cancer. This can involve drug treatment or chemotherapy, radiation therapies, and surgery. Recently, authorization of Roche’s Avastatin has been revoked by US Food and Drug Administration, according to United Stated health officials.

According to the Product Information of Avastatin, “it is a tumor-starving (anti-angiogenic) therapy. Avastin is not chemotherapy and works differently. The purpose of Avastin is to block a protein called vascular endothelial growth factor, or VEGF. Normal cells produce VEGF, but cancer cells overproduce VEGF. Blocking VEGF may prevent the growth of new blood vessels that feed tumors.”

“The most common side effects of Avastin that occurred at >10% and at least twice the control rate include nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain, and inflammation of the skin.”

The report made by the US Food and Drug Administration shows that the use of Avastatin as a drug treatment for breast cancer among individuals who are affected by the disease showed that the drug had not been safe and effective. Although the authorization for the drug Avastatin has been revoked for the treatment of breast cancer, the drug will still be available and remain in the market as a treatment for other malignancies such as colon, lung, kidney, and brain cancer, according to US Food and Drug Administration.

Margaret Hamburg, FDA Commissioner, said:

“FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use.”

The revoking of authorization of Roche’s Avastatin as a treatment for breast cancer was based on established studies which revealed that those women who are taking Avastatin for their metastatic breast cancer had potentially life threatening risk while there is no proof that the use of the said drug can actually provide beneficial effect in treating breast cancer by delaying the growth of tumor cells. But, Roche was unhappy with the revocation of the authorization, thus they decided to appeal.

Moreover, other recommendations from an exper panel appear which showing that the drug which is also known under the generic name of bevacizumab, can actually cause various health risks such as hypertension or severe high blood pressure, hemorrhage and does not increases the survivability rate of women who have breast cancer and are taking the said medication.




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