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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: Twitter: Dereklowe

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November 18, 2011

Avastin's Metastatic Breast Cancer Approval Revoked

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Posted by Derek

Here's the FDA's decision (70 page PDF). As I've said here many times, I think that this is the right decision. A key section:

. . .As noted, FDA may withdraw an accelerated approval when confirmatory trials fail to confirm clinical benefit, or when the evidence does not show that the drug is safe and effective. However, the agency also carefully considers the effect on current and future patients of such a decision, and there may be circumstances, in particular cases, that would lead the agency to conclude that it would be appropriate to exercise discretion and leave an approval in place pending further study. This is not such a case.

Accelerated approval was based on the results of E2100, which showed an effect on (progression-free survival) that would be large enough to constitute clinical benefit, despite the known risks of Avastin, which are serious. However, we now have five trials, and they have substantially changed our view of this drug. The current evidence no longer supports a determination that it has a strong effect in metastatic breast cancer, and it appears likely that its effects are very weak, while the risks associated with this drug remain serious and potentially life-threatening.

There's going to be a lot of commentary, not all of it very informed, to the effect that this decision is a price-driven attempt to bring down health care costs, an assault on medical progress, the opening salvo of Obamacare, and so on. Wrong.

Avastin doesn't work as well as we thought it did for this indication. If you're going to believe in medical progress at all, you have to believe in what multiple well-controlled clinical trials are telling you - trials carried out, keep in mind, by the drug company that has every interest in having them come out favorably. But they didn't. On medical grounds, on scientific grounds, this was the right decision.

Comments (12) + TrackBacks (0) | Category: Cancer | Regulatory Affairs


1. 4merchemist on November 18, 2011 11:32 AM writes...

a biomarker is the key.. it obviously works in a small proportion of patients.. they need to work out why. drugs such as avastin are going to find it increasingly difficult unless they have a target population in mind.

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2. barry' on November 18, 2011 12:36 PM writes...

all FDA approvals in onco--if the phase-III trial didn't show a change in mortality/survival--should be contingent on showing that in "Phase-IV" i.e. out there in the world after it has hit the market. All credit to Pazdur and the FDA who got it right this time.

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3. anchor on November 18, 2011 2:38 PM writes...

Derek: How much money Hoffman-LaRoche/Genentech stands to lose because of this FDA decision? Those who have been hopelessly watching (of course, from the side lines) big pharmaceuticals eliminating thousands of jobs, I for one was proud that Roche was above the fray. Seems like this could action by the FDA could be the straw that broke camel's back.

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4. MolecularGeek on November 18, 2011 3:17 PM writes...

I don't think that this is going to be the straw that broke the camel's back. The FDA only withdrew the indication for metastatic breast cancer. The kidney, lung, brain, and colon cancer indications are still alive and well. The ones who are screaming the loudest right now are people who are desperate for any last ditch cure for breast cancer and who are upset that their insurance companies are less likely to pay for it now.

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5. Jim Moko on November 18, 2011 5:43 PM writes...

People always wonder why we can't cure cancer with all the millions of dollars people are donating. This gives a good explanation on why cancer can't be cured right now.

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6. Cellbio on November 18, 2011 9:20 PM writes...


Where is the evidence it works in a subset of patients?

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7. Anonymous on November 18, 2011 11:21 PM writes...

HAHAHA...Count the days Nutley (or should I say Buttley??).

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8. Gambler on November 19, 2011 6:51 AM writes...

Well, this was a long time coming. Oncology has been a bit of a wild west indication lately. Anything goes, minimal extensions in progression free survival gets you an approval. It's time these therapies are held to a more reasonable standard. Either figure out the subpopulation the therapies work in or drop them. Things had been moving in this direction anyway because of payer pressure, and this decision should help more.

I have little sympathy for Roche/Genentech on this one. They handled themselves poorly and turned themselves into snake-oil salesmen, giving false hope to many desperate breast cancer victims. This once proud institution should be ashamed.

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9. NoDrugsNoJobs on November 19, 2011 2:01 PM writes...

Since this drug is approved by the EMEA, it would be intersting to read through their minutes and records and find out why they did approve it. The fda's decision is necessarily going to be an advocacy position on their point of view and therefore one is likely to be persuaded to agree absent different point of views. Just saying.....

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10. @7 on November 20, 2011 1:57 PM writes...

Hey now, are you implying that legacy Hoffmann-LaRoche folks are more expendable than legacy Genentech folks?

Also, why are the small-molecule folks hating on the biological therapuetics?

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11. Kieth on November 20, 2011 4:18 PM writes...

Derek, thanks for your remarks. Conservative to right-wing commentators have been attacking this decision as a (peripheral) wedge of the "death panel" medical view. I am normally sympathetic to right wing views but as comments above note you can still buy the treatment with your own money, right? it's hard for me to understand the outrage.

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12. Anonymous on November 20, 2011 7:03 PM writes...

Although Avastin originated at genentech, just look at the erosion of the nutley site over the past 2 yrs. Nutley used to be the US headquarters for pharma (now it's genetech). George Abercrombie, a great and respectable leader left nutley abruptly. Operations, development and others have been moved to genentech (many jobs lost) from nutley. Even Nutley HR is based at GNE. The 2011 layoff severence packages (including healthcare) for displaced nutley workers are coming from genetech. Buildings are being demolished in nutley. The try to hide this by saying that they "are expanding" and just opened a new facility for development. Wake up people, the new nutley facility is simply a renovation of on floor of building 115. This had to be was a wasteland and didn't support resale!! They have also been pumping/monitoring the ground water around the nutley site and fixing up the front gate (ie: curb appeal...)

Nutley used to be one of the key research sites (the TRIPOD including Basel, Nutley and Genentech). Now it's Basel, SHANGHAI and Genentech. Major downsizing in nutley (38% headcount reduction) while expanding in SHANGHAI.

It is clear what's going on even to a genentech employee with half a brain in his / her head!!!

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