FDA Revokes Avastin As Breast Cancer Treatment

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The fate of Avastin as a breast cancer treatment has finally been decided. And U.S regulators did not come down on the side of Swiss drug maker Roche Holding (RHHBY).

The FDA announced today it is removing the approval of Avastin as a treatment for metastatic breast cancer because it isn’t safe and effective for that type of cancer.

The decision could put as much as $1 billion in sales at risk. At $6 billion a year, Avastin remains Roche’s biggest-selling product, and as Barrons.com pointed out earlier this year, global sales have been growing. Meanwhile, Roche reportedly still sees peak sales exceeding $7 billion.

Also,*Friday’s FDA decision hardly came out of left field.

In 2010, the FDA’s drug division concluded that it wanted to revoke Avastin’s approval for breast cancer, and Roche appealed that decision to the FDA commissioner. In June, an outside*panel of experts voted 6-0*in favor of withdrawing Avastin’s breast cancer indication.

So it’s little wonder that Roche’s U.S.-listed shares aren’t feeling any pain today. At $38.85, the American depositary receipts have climbed 26*cents or 0.67%.

Avastin literally starves tumors of their blood supply. But side effects include severe bleeding, heart attacks and heart failure. *And according to FDA Commissioner Margaret Hambur, “women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth that would justify those risks.”

Avastin’s approval for certain types of colon, lung, kidney and brain cancers remains intact. And because the drug is already on the market for other cancers, U.S. doctors can still prescribe it “off label” for breast cancer, though Roche will not be allowed to market the drug for that use.

Federal and private insurance plans are reviewing their coverage options.

Roche doesn’t plan to appeal the decision. Still, it will continue a study seeking to identify breast cancer patients who would benefit most from Avastin.



Original Article Source by Barrons.com