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Avastin for cancer treatment gains FDA approval

New drug approved for cervical cancer in combination with chemotherapy for longer survival period.

Originally posted by Vinitra Nathan on Daily Digest News

Courtesy of Daily Digest News

Genentech’s bevacizumab, referred to as Avastin on the market, has gained approval for use in combination chemotherapy for late-stage cervical cancer. The U.S. Food and Drug Administration detailed that the approval allows for the treatment of recurrent, persistent or metastatic cervical cancer with Avastin in conjunction with other chemotherapy drugs cisplatin and paclitaxel or in conjunction with paclitaxel and topotecan.

“Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin,” said Richard Pazdur, M.D., of the FDA’s Center for Drug Evaluation and Research. Due to Avastin’s demonstrated efficacy and safety over other therapies in its league, the FDA granted the drug an expedited review process, and approved it under the priority review process.

Avastin is an angiogenesis inhibitor that functions to reduce a tumour’s ability to thrive by targeting its formation and maintenance of blood vessels, a process known as angiogenesis. The cancerous cells are dependent on the blood vessels for growth, as blood carries oxygen and other necessary molecules. Thus, the cancerous cells start to die off when their blood supply is interrupted.

Genentech conducted several clinical trials on the drug prior to submission for review. The company conducted studies involving up to 450 patients with recurring, persistent and late-stage cervical cancer. The studies saw a consistent improvement in overall survival to 16.8 months with treatment of Avastin combined with chemotherapy, as compared to 12.9 months with chemotherapy alone.

Side effects include appetite loss, fatigue, elevated blood pressure, headaches and weight loss. The company recommended women are pregnant or considering pregnancy to consult with their healthcare practitioners about the risks to the foetus associated with Avastin.

“With this approval, women with advanced cervical cancer now have the option of Avastin plus chemotherapy to help them live longer than with chemotherapy alone,” said Genentech’s chief medical officer Sandra Horning, M.D. “Cervical cancer is most commonly diagnosed in women between the ages of 35 and 44, and until today, chemotherapy was the only approved treatment option for women whose cancer recurred, persisted or spread,” she added.

According to the National Cancer Institute, up to 12 000 American women will be diagnosed with cervical cancer, with 4000 losing the battle with the disease in 2014. Cervical cancer is the result of the human papillomavirus (HPV) causing cells to become cancerous. There is a large availability of vaccines to prevent many types of HPV.