Roche's Avastin gets FDA reprieve--for now

Is the FDA having second thoughts about following its advisory panel's recommendation on Avastin? Maybe, maybe not. In the midst of lobbying from breast cancer patients and their families, the agency has extended its review of the drug for that use.

The extension is a procedural thing, but in announcing the move, the FDA's Erica Jefferson told the New York Times, "We realize there are limited effective treatment options for women with metastatic beast cancer and the FDA takes seriously its obligation to carefully weigh all the scientific data and research.''

Whatever it ultimately decides, the FDA's announcement on Avastin use will come later rather than sooner. The FDA had expected to decide by last week, but after the advisory panel voted in July to yank that approval, Roche submitted new data to the agency. So, FDA is allocating another 90 days for its review.

The new decision date conveniently comes after the November elections. Congressional types are among those lobbying FDA to keep the breast cancer indication--and accusing it of "rationing" healthcare if it doesn't. The impassioned pleas from patients and families have spread beyond the Wall Street Journal to The Hill's Congress blog. "During the review period, the approval status and availability of Avastin for metastatic breast cancer will not change,'' Jefferson emphasized.

- check out the Genentech release
- see the NYT story
- get The Hill's blog post

ALSO: Roche's Avastin failed to meet the main goal of a late-stage study in early colon cancer; the company had hoped the drug, effective in late stages of colon disease, would be useful in early stages as well. Story | Report

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