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FDA Votes To Remove Avastin From Approved Breast Cancer Drugs

By Stephanie Lucero, Carol Cavazos & Jessica Huseman, CBS 11 News
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DALLAS (CBSDFW.COM) - One of the most prescribed breast cancer medications may soon no longer be available for patients who receive the diagnosis. A special panel of the U.S. Food and Drug Administration voted Wednesday to recommend that Avastin no longer be an approved label for the treatment of breast cancer.

“I’m somewhat disappointed the vote was a no and we get to live with that,” said Jaya Juturi, an oncologist with Texas Health Presbyterian Hospital Dallas.

One of her patients reacted with equal disappointment. “I don’t think any drug that is potentially helpful should be removed from the arsenal that allows a doctor to treat her,” said Michelle Wirth, who was first diagnosed with breast cancer 24 years ago. “To take away one would be to send our soldiers to Afghanistan without bullets.”

Avistan is used to treat numerous types of cancers. Last December the FDA moved to remove it from the list of drugs approved for treatment for breast cancer. Doctors say Avistan targets aggressive tumors by blocking the blood supply created by the tumors, but Avistan has reportedly only been effective in a small percentage of breast cancer patients.

“I did have a metastatic breast cancer patient several months into the treatment the Avastin needed to be discontinued due to bleeding complications. The patient has been off Avastin and is now doing well,” said Dr. Asad Dean with Texas Oncology in Fort Worth.

Dr. Juturi says some of her patients have seen benefits and their quality of life has maintained at a high level, and Wirth said she believes Avastin helped her continue to lead an active lifestyle as a substitute teacher and musician.

In a statement released Wednesday, the Dallas-based Susan G. Komen Foundation urged the manufacturer of the drug, Genetech/Roche, to continue research on a biomarker for Avastin in order to determine which women will benefit from taking the drug.

In the meantime, the foundations said it wants to ensure “that women who are using Avastin, and for whom it is working, can continue to have access to it, that their insurers will continue to pay for it, and that the drug’s manufacturer continues making the drug available to women through its patient support programs, which we hope will be expanded.”

The FDA panel voted unanimously to remove Avastin from the approved list of drugs to treat breast cancer. The public will be allowed one month to voice concerns and FDA Commissioner Margaret Hamburg is expected to announce her final decision in late July.

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