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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« Science Jobs Roundtable - Day Four | Main | Politics in the Lab »

December 17, 2010

The Avastin Decision: A Reality Check

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Posted by Derek

So the FDA did indeed rescind their conditional approval for Avastin in metastatic breast cancer. I think that this was the right thing to do, given that the weight of the evidence now says that it doesn't do any good in that situation. Problem is, there are a lot of people trying to make political points off this decision, saying "See? We told that Obama's health care plan would lead to this. Life-saving medical breakthroughs, pulled because some bureaucrat says that they're too expensive".

Wrong. And I say this as someone who still thinks that the health care plan is a bad idea, poorly implemented. It would be good if other people opposed to it could resist the any-weapon-to-hand temptation in this case, but that's politics for you. (I'd hoped back in August that we could avoid this stuff, but that was always a long shot). The FDA is not in the business of considering costs, just safety and efficacy. And the balance between those two, in the case of hard-to-treat metastatic breast cancer, is not in Avastin's favor. If we're going to speed things up with conditional approvals, we're going to have to be able to take them back when they don't work out. This one didn't.

Here's some good background from WebMD on this decision, and more from Science-Based Medicine on the clinical evidence. That's the evidence we have, and that's why I think this was the right decision.

Comments (9) + TrackBacks (0) | Category: Cancer | Regulatory Affairs


COMMENTS

1. patewart on December 17, 2010 11:25 AM writes...


You guys should stop complaining because, one the health care we have now isnt as good as it was supposed to be. also the law has just been signed so give it some time. so if u want to say u have the right to choose tell that to ur congress men or state official. If you do not have insurance and need one You can find full medical coverage at the lowest price search online for "Wise Health Insurance" If you have health insurance and do not care about cost just be happy about it and trust me you are not going to loose anything!

Permalink to Comment

2. anon on December 17, 2010 3:24 PM writes...

The drug is effective in some occasions, the FDA is just "lying". The decision was based on the cost of the drug, once again, the FDA is "lying".

Permalink to Comment

3. David Young on December 17, 2010 3:39 PM writes...

As an oncologist, I agree with the decision by the FDA. Clearly, there is more to fighting cancer than providing an anti-angiogenesis drug. Or, perhaps it is that Avastin is an ineffective anti-angiogenesis drug in the setting of metastatic breast cancer.

Avastin was promoted for use in breast cancer in conjunction with Taxol, a reputable chemotherapy drug. One would come to the conclusion now, that women with breast cancer who received Avastin and Taxol and experienced regression of cancer, experienced regression on the basis of the Taxol alone. If there were individuals who had an added benefit with the Avastin (and how would you know?) then there must be other individuals who were harmed by the Avastin because the overall outcome was that Avastin did not improve overall survival.

Avastin seems to be a good drug for colon cancer (but I am not sure just how good) but I am somewhat skeptical for lung cancer and now I am very skeptical for breast cancer.

Do we need a more potent anti-angiogenesis agent?.... or do we just need to keep on plugging away at other strategies in fighting cancer (for where there are many)?

And yes, I am disturbed with the overall price tag for Avastin... 4 ti 8 thousand dollars a month depending on dose..... for a drug that has no or limited single agent activity (except for glioblastoma.)

David

Permalink to Comment

4. barry on December 17, 2010 3:50 PM writes...

This looks like a regulatory success story. All FDA drug approvals should be provisional until/unless the drug (usually after release, i.e. Phase IV) can show real benefit. For a cancer drug, that probably means delta-mortality rather than a delay of progression.

Permalink to Comment

5. barry on December 17, 2010 11:22 PM writes...

This looks like a regulatory success story. All FDA drug approvals should be provisional until/unless the drug (usually after release, i.e. Phase IV) can show real benefit. For a cancer drug, that probably means delta-mortality rather than a delay of progression.

Permalink to Comment

6. medbio on December 18, 2010 9:27 PM writes...

Roche (Genentech) has no one to blame but themselves for not being innovative enough to come up with a companion diagnostic assay to better identify the patients who would benefit. Instead of letting the marketing droids run wild try to make off-label usage official, they should get back to doing meaningful science.

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7. barry on December 18, 2010 9:36 PM writes...

Genentech knows better than anyone how narrowly they missed a finding of "non-efficacy" in the herceptin trials. In retrospect, they learned that they could have identified the responders by FISH. In that population, their response rate was dramatic.

Permalink to Comment

8. cliffintokyo on December 20, 2010 4:33 AM writes...

The fallout for FDA looks like being considerable, because of the continuing outcry from the political blow-hards who don't *do* science.
Agree with #5 barry that this case points up the failings of the accelerated regulatory approval process. It is not good for your public image if your Agency appears to be back-tracking on its decisions to the *uninformed*.
We need to make it crystal clear that fast-track means *conditional approval*, (which has been conveniently *forgotten* by all the complainers), or abandon this flawed regulatory process.
The furore might actually end up being of benefit to FDA, by creating an opportunity to get these notorious regulations revised.

Permalink to Comment

9. Old Timer on December 21, 2010 9:15 AM writes...

Has anyone seen the lawyer ads on TV soliciting people who have taken Avastin to sue? How did they get that commercial out so fast?

Permalink to Comment

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