[Ip-health] FDA Approves Avastin For Breast Cancer ....rejected the recommendation of its advisory panel

[Joana Ramos]

Also of interest is Merrill Goozner's piece on the topic in this week's
/GoozNews/, written before the approval was finalized, in which he
suggests a new mechanism o track outcomes for use of Avastin for breast
cancer.

<snip>

> The approval also bolsters an industry tactic called label expansion,
> which is used to squeeze additional revenue out of a medication. In
> the case of Avastin, which is already approved to treat colon and lung
> cancer, Genentech may reap an additional $1.3 billion a year in revenue.

Joana
----------------- original article-------------------

www.pharmalot.com

FDA Approves Avastin For Breast Cancer
February 22nd, 2008 4:32 pm By Ed Silverman

This decision could represent a major shift in standards for assessing
the effectiveness of cancer meds. In granting approval, the FDA rejected
the recommendation of its advisory panel, which last December voted 5-4
against the drug, because the benefit in slowing tumor growth wasn=92t
believed to be worth the added risk of serious side effects, including
high blood pressure and death.

At issue was whether slowing tumor growth - known as progression-free
survival - for an additional 5-1/2 months in metastatic breast cancer
merits approval, even though Avastin wasn=92t shown to extend life. The
question, of course, resonates far beyond any one drug as the agency
grapples with increasingly vocal cancer patients and their advocates,
who insist any benefit is important.

For drugmakers, the approval is an important signal, because it can be
expensive to conduct the lengthy trials needed to prove a drug can
extend life. The approval also bolsters an industry tactic called label
expansion, which is used to squeeze additional revenue out of a
medication. In the case of Avastin, which is already approved to treat
colon and lung cancer, Genentech may reap an additional $1.3 billion a
year in revenue.

=93We felt this is an effective drug for breast cancer,=94 Richard Pazdur,
director of the agency=92s Office of Oncology Drugs, tells Bloomberg News,
adding that the FDA still believes survival is the =93gold standard=94 for
cancer drugs, and if further Avastin studies don=92t demonstrate a
benefit, the agency may require another advisory panel.

The FDA=92s decision may now open the door for other cancer meds to be
approved if studies find the meds can shrink tumors, although some docs
worry patients may not really benefit. =93If FDA sets a precedent of
approving a drug based on progression free survival, people are afraid
they may stop looking at survival as the most important endpoint,=94 Kay
Dickersin, director of the Center for Clinical Trials at Johns Hopkins
University, tells the Associated Press.

=93The FDA has lowered the bar on the approval of breast cancer therapies.
At a time when many questions are being raised about how the FDA
approves drugs for market, today=92s decision is a victory for drug
companies, but not for patients,=94 Breast Cancer Action executive
director Barbara Brenner says in a statement headlined =91Patients Lose,
Genentech Wins.=92

Another patient advocate disagrees. =93The benefits we=92re looking at with
Avastin matter because they give patients hope,=94 Margaret Kirk,
president of Y-Me Breast Cancer Organization. =93Without disease
progression they may survive to see a discovery that can help them in
the future.=94

-----------------------
Joana Ramos, MSW
Cancer Resources & Advocacy
Seattle WA USA
+1-206-229-2420
http://ramoslink.info/
www.bmtbasics.org