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Avastin Loses Approval For Breast Cancer Treatment

November 19, 2011

The U.S. Food and Drug Administration (FDA) has ruled that the drug Avastin should no longer be used by breast cancer patients because there is no proof that it can prolong their lives and because of the medicine’s dangerous side effects.

According to the Associated Press (AP), the ruling had been “long expected,” but was “sure to disappoint women who say they have run out of other options.” The wire service said that FDA Commissioner Dr. Margaret Hamburg said that the decision was a difficult one, but that she believed that patients must be confident that the medication that they take is safe and effective.

“Sometimes, despite the hopes of investigators, patients, industry and even the F.D.A. itself, the results of rigorous testing can be disappointing,” Dr. Hamburg told reporters Friday, according to Andrew Pollack of the New York Times. “This is the case with Avastin when used for the treatment of metastatic breast cancer.”

Pollack adds that the drug, which will remain on the market as a treatment option for other forms of cancer, including colon, kidney, and lung cancer. However, it can no longer be prescribed for breast cancer.

That means that insurance companies will likely no longer cover the medicine, though officials told the New York Times that Medicare would still pay for the drug for breast cancer patients. Avastin costs approximately $88,000, and has reportedly caused severe side effects such as high blood pressure and hemorrhaging, Pollack reported on Friday.

Some experts disagreed with the decision, insisting that some patients could benefit from the drug.

“The bottom line is that they are throwing out the baby with the bathwater,” Dr. Elisa Port, co-director of the Dubin Breast Center of Mount Sinai Hospital in New York, told Alina Selyukh and Anna Yukhananov of Reuters. “There absolutely may be subsets of carefully chosen breast cancer patients who benefit from Avastin.”

Avastin is manufactured by Swiss pharmaceutical company Roche.

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Source: RedOrbit Staff & Wire Reports



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