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FDA Roche Breast Cancer Drug Approval: New Drug Could Help Women Avoid Surgical Removal

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  • breast cancer
By Brittney R. Villalva, Christian Post Reporter
September 10, 2013|11:51 am

A new drug that can help to prevent the growth of tumors in the early stages of breast cancer has received positive review from the Food and Drug Administration.

Experts believe that a new drug called "Perjeta" could help to prevent the growth of tumors in women who have been diagnosed with early stages of breast cancer. The drug is still in the middle levels of testing, but could prove to be a more effective medication than those that are currently on the market.

Perjeta could become the first approved drug to be issued as first line treatment. Surgical removal is typically the first line of treatment for any form of cancer. But Perjeta could help to shrink existing tumors either making them easier to removed or making it unnecessary to remove them at all.

"FDA scientists said women who received the drug Perjeta to treat early-stage breast cancer had significantly fewer tumors than women who received older drug combinations," documents obtained online by the Associated Press read.

In July the FDA approved the drug for Priority Review- a process typically reserved for drugs that the FDA believes have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

"The impact of treatment in breast cancer is greatest in the early stage, before the cancer has spread to other parts of the body," said Hal Barron, M.D., chief medical officer and head, Global Product Development in a July press release. "We look forward to working with the FDA to bring this potential option to people with HER2-positive early stage breast cancer as soon as possible."

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The drug works to kill cancer affected cells more rapidly and when used in conjunction with chemotherapy, could help to increase the effectiveness of treatment.

On Thursday the FDA will seek the advice of an outside panel who will vote on whether the benefits of the drug outweigh the side affects according to AP. Common side effects include nausea and hair less; more serious effects could include reduced heart function.

 

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