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An Avastin reading list


The Avastin saga has so many angles and implications, it may be quite some time before we all know what to make of it. Here's a quick reading list to help you get up to speed, as well as viewpoints from various sources. Please feel free to add your own in the comments section.

1. Dr. Len, of the American Cancer Society, described the two-day hearings and their implications with "The FDA's Decision to Remove Approval for Avastin in Metastatic Breast Cancer is Caught Between Data and Emotion" and "FDA Advisors Vote Unanimously That Avastin Approval Should Be Withdrawn, And You Could Hear The Pain." You can also read over his live tweets at twitter.com/drlen.

2. "Do the FDA Avastin hearings mark the end of an era?" by CURE's own editor-in-chief and breast oncologist, Dr. Debu Tripathy. He writes: "The process of testing new cancer agents has forever changed because of this. It is now necessary to define predictive factors at the same time a drug is initially being developed. Not only is FDA approval in jeopardy, but drug companies can no longer afford the cost of huge trials to show a tiny difference in outcomes. The FDA hearings mark a milestone in this turn - the end the old era of cancer drug development."

3. "Memo to Avastin Protestors: The Agency You Want is in Baltimore, Not White Oak" - "Advocates urge FDA to maintain indication for Avastin in metastatic breast cancer. But their reason isn't really an FDA issue at all: they want to make sure use is still reimbursed. That decision goes to a different agency - CMS - no matter what FDA does next."

4. Column from Oncology Times "Avastin: What Went Wrong" - The column ends with a good summation: "We need to work through the tears and rise above them. And do better. We must do better."

5. Blogger who favors keeping approval of Avastin: KatherineMBC has been very vocal about the process, including her latest blog: "An open letter to Larry 'Let's Muzzle the Cancer Patients' Husten" at ihatebreastcancer.wordpress.com.

6. Blogger who favors withdrawal of Avastin: Katie at uneasypink.com blogged about the proceedings, ending with "The Vote." She writes: "...The follow-on studies failed to verify the clinical benefit and the risks are significant. Genentech plans to move forward with further studies. I applaud the FDA for sticking with the available science rather than being swayed by the sticky politics of this decision."

7. Postmarket Drug Safety Information for Patients and Providers from the FDA includes information about the proceedings from the agency, including: "The public hearing on the Center for Drug Evaluation and Research's December 2010 proposal to withdraw approval of the metastatic breast cancer indication for Avastin is now complete. The Center and Genentech are scheduled to provide additional written submissions by July 28, 2011, and the docket will remain open for public comment until that date."

8. The European Commission just approved Avastin for metastatic breast cancer using the same studies the FDA advisory committee pored over for the two days during the hearings. As you can see the story will be ongoing for quite a while. Stay tuned. (For backstory on the Avastin saga, read "Hurdles on the Faster Track.") If you'd like to add to the reading list, please leave comments below.

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