Cancer Drug Ruling Will Have Wide Impact

[flashl]

Source: Chicago Tribune

WASHINGTON - A decision expected Friday on federal approval for Genentech's Avastin cancer drug could have ramifications for all companies developing cancer medicines.

Genentech made its case for Food and Drug Administration approval of Avastin using a widely debated measure of drug effectiveness that focuses on tumor growth, not patient survival.

...

In December, a panel of outside FDA advisers voted 5 to 4 against Genentech's application, arguing the drug's benefits did not outweigh dangerous and toxic side effects]. FDA is not required to follow the panel's advice, although it often does.

At issue is how the agency judges the effectiveness of cancer treatments. Traditionally, FDA only approved cancer drugs that extended the lifespan of patients. However, in recent years companies have studied alternate measures of a drug's effectiveness. One of the most controversial measures is so-called progression-free survival, or how long the drug halts the spread of cancer.

Read more: http://www.chicagotribune.com/features/lifestyle/health/sns-ap-cancer-treatment-fda,1,2444778.story

---

OK, fellow sacks of water (Trekkies knows what this means). Genentech is saying to me, the cure is worse than the disease, but that's OK.

[dysfunctional press]

1. i thought we were ugly sacks of mostly water...?

:shrug:

[flashl]

2. Right! nt

[BadgerKid]

3. But lifespan extension isn't always sufficient either

as has been the case with the drug Provenge for prostate cancer. Part of the back story is that there were unreported conflicts of interest among the FDA board members (one member was on the board of a pharma working on a competing drug), and the panel declined to approve that drug.

IMO the FDA's house needs cleaning also.

[pushycat]

4. Our cancer specialist says Avastin does not help that much....

and it makes it harder for the body to heal from surgery. Patients should wait 3 or more months after using it before having surgery. The drug company claims patients need only wait 6-8 weeks but that is not true according to practicing oncology surgeons we've spoken with.

[flashl]

5. Genetech wins U.S. approval to use Avastin to treat breast cancer

SAN FRANCISCO: Genentech won U.S. approval to market its top-selling treatment Avastin for women with breast cancer, giving the company a chance to add more than $700 million in sales this year.

Avastin was cleared for marketing by the U.S. Food and Drug Administration, combined with paclitaxel chemotherapy, for women whose breast cancer had spread, the company said in a statement. Avastin, the first product to work by cutting off blood supply to tumors, was already approved for colorectal and lung malignancies.

The FDA overruled one of its advisory panels, which recommended 5-4 in December against approving the medicine for breast cancer. The committee said Avastin's benefit of slowing the spread of tumors was not worth the risk of serious side effects, including high blood pressure and death. Avastin generated $2.3 billion in U.S. sales in 2007.

International Herald Tribune