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Showdown Over Cancer Drug – WSJ.com

Showdown Over Cancer Drug – WSJ.com.

At the very least, Avastin should be “grandmothered” for those women who are on it. Let’s face it, the side effects are not as scary as metastatic breast cancer. There are some reports that the head of the Committee involved actually tightened the criteria for the follow up studies:

 

The odds are also stacked against Genentech because it will face a six-member appeals panel with five members who belonged to another panel that reviewed Avastin for breast cancer last summer. All of them voted against it.

In that episode, Dr. Pazdur rigged the review process against Avastin. Genentech was supposed to show that Avastin improved “progression-free survival,” the time women live without their disease spreading or worsening. Over three rigorous clinical trials, and in combination with chemotherapy, it did so, even if the results were less statistically robust in the follow-up studies. But Dr. Pazdur and his staff reviewers unilaterally revised the approval “endpoints” that Avastin was supposed to hit, to undermine the drug.

More:

 

A.M. Vitals: FDA Appeals Panel to Hold Avastin Hearing This Week – Health Blog – WSJ.

Avastin for breast cancer? FDA hears patients, experts debate drug – HealthPop – CBS News.

 

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