FDA Approves Avastin Use for Ovarian Cancer Resistant to Platinum-containing Chemotherapy

Cancer drug Avastin is already enjoying wide acceptance in Europe after it was approved for use earlier in the year. The same could happen in the United States soon as the Food and Drug Administration recently approved the use of Avastin as a treatment option alongside chemotherapy in battling platinum-resistant, recurrent ovarian cancer.

Roche announced the approval Monday, based on results from a Phase III AURELIA study showing that using Avastin in combination with chemotherapy cut risks of worsening or death by up to 62 percent in women who have platinum-resistant, recurrent ovarian cancer compared to those who underwent chemotherapy alone.

"Avastin plus chemotherapy is the first new treatment option for women with this difficult-to-treat type of ovarian cancer in more than 15 years," said Roche Global Product Development Head and chief medical officer, Sandra Horning, M.D.

With this approval, Roche's Avastin is now labeled to treat six distinct types of tumors.

The AURELIA study whose results were used to garner approval for Avastin is a company-sponsored, randomized, open-label, multicentre, phase III study involving 361 women with platinum-resistant, recurrent fallopian tube, primary peritoneal, or epithelial ovarian cancer who have not received over two anti-cancer treatment regimens before taking part in the trial. The participants were randomly assigned one of six treatments involving paclitaxel, liposomal doxorubicin, or topotecan with or without Avastin.

As a cancer drug, Avastin works by targeting and inhibiting the release of vascular endothelial growth factor, a key component in tumor growth as it is produced during angiogenesis or the process where a tumor develops its own blood supply. By keeping tumor growth at bay, Avastin is able to complement the functions of other anti-cancer treatments.

Over the course of 10 years, Avastin has become a fundamental part of treating cancer today, having treated more than 1.5 million patients so far. While the drug is already approved for use against six tumor types, a comprehensive clinical program is in place, involving over 500 clinical trials to determine if Avastin will be effective in fighting over 50 more types of tumors.

All over the world, ovarian cancer is ranked seventh as the most commonly diagnosed form of cancer in women. About 230,000 new cases are diagnosed every year worldwide, with the cancer claiming around 150,000 lives annually. At that rate, ovarian cancer is considered to be the deadliest form of all gynecological cancers around.

Ovarian cancer becomes platinum-resistant when it worsens within six months after the completion of platinum-based chemotherapy. In the U.S., a quarter of all women who relapsed after their initial treatment will have platinum-resistant ovarian cancer.

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