OT: FDA Approves Tylverb, A Useless, But Very Expensive, Anti-Breast Cancer Drug

The Food and Drug Administration will eventually rue the day it

allowed GlaxoSmithKline PLC to market its new anti-cancer drug,

Tykerb. GSK is a company that puts profits ahead of everything. GSK

is facing a multi-billion lawsuit loss with the way it fraudulently

handled drug test results of its drug Paxil as an anti-depressant for

teenagers. Paxil in drug trials worked as well as a placebo on

teenage depression, with one big differnece. Paxil teenage users

started committing suicide at alarming rates. The BBC Panorama show

of 1/29/07, "Secrets of the Drug Trials," had the whole sordid story.

How GSK has maintained patent protection for Paxil since 1981 is a

whole other story, showing how GSK's predecessor gamed the system by

providing false information to regulators.

Burroughs-Wellcome, bought in 2000 by what is now GSK, made a fortune

off the AIDS drug AZT, even though US government scientists developed

the drug at taxpayer expense. The Clinton administration dropped the

ball on the lawsuit contesting the right of Burroughs-Wellcome to

obtain an AZT patent, no surprise considering Clinton AG Reno's track

record showing complete incompetence but a great ability to lie to the

American public. But to secure their profits against any more pesky

lawsuits, Burroughs-Wellcome let itself be taken over.

All other things being equal, Tykerb will probably turn out to cause

cardiac infarctions in women under 50, a fact hidden in the GSK drug

trials for this essentially useless (but very expensive) drug. A

$2,900 a month drug cost for a two month delay in tumor growth, based

on drug trials cut short before there could be any finding that this

delay was a statistical anomaly. Welcome to the world of corporate

greed.

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Tuesday, Mar. 13, 2007

FDA Approves Advanced Breast Cancer Drug

By AP/ANDREW BRIDGES

http://www.time.com/time/printout/0,8816,1598883,00.html

WASHINGTON - Women with an aggressive form of advanced breast cancer

that other treatments have failed to stop gained a new option Tuesday

with the approval of a novel drug - but how much benefit it offers is

unclear.

The GlaxoSmithKline PLC drug, Tykerb, is to be taken once daily in

pill form and is meant for women who have received prior treatment

with the intravenous drug Herceptin and older chemotherapy drugs

called taxanes and anthracyclines, the company said. The Food and Drug

Administration said it approved Tykerb for use in conjunction with the

chemotherapy drug Xeloda.

Glaxo said Tykerb would be available in two weeks. It will cost about

$2,900 a month, the company said.

The initial results of a study reported last year showed that Tykerb

in combination with Xeloda delayed tumor growth for an average of 8

1/2 months, or about twice as long as Xeloda alone. Tykerb worked so

well that the international study was stopped early and all

participants were offered the drug.

However, Glaxo said a later analysis of the results of that study

showed the delay actually was closer to nearly seven months for women

on both drugs, versus almost five months for those on Xeloda alone.

The FDA said it was too early to know if women taking Tykerb and

Xeloda would live longer than those taking the latter drug alone. The

lack of that information has left one advocacy group disappointed.

Survival - and not progression of disease - gives a truer picture of a

cancer drug's efficacy, Barbara A. Brenner, the executive director of

Breast Cancer Action, told the FDA in a March 5 letter. "The FDA

should not approve drugs that have not shown either a survival benefit

or improved quality of life for breast cancer patients with metastatic

disease," Brenner's letter read in part.

FDA drugs chief Dr. Steven Galson said Tykerb expanded the options

available to women with a type of advanced breast called HER2 positive

when it has metastasized, or spread. "Today's approval is a step

forward in making new treatments available for patients who have

progression of their breast cancer after treatment with some of the

most effective breast cancer therapies available," Galson said.

Tykerb, like Herceptin, is part of a new generation of cancer

medicines that more precisely target tumors without killing lots of

healthy cells. Herceptin has been an important option for many women

with advanced, HER2 positive breast cancer, but eventually it stops

working and women succumb to the disease.

Both drugs target a protein called HER-2/neu, which tumors make in

abnormally large quantities in roughly one-fourth of all breast

cancers. While Herceptin targets the outside of the HER2 protein,

Tykerb works from the inside of the cell. Because of that difference,

Tykerb works in some HER2 positive breast cancers that have been

treated with Herceptin but no longer benefit from the older drug, the

FDA said.

Generally, women with HER2 positive breast cancer face a greater risk

of disease progression and death. Approximately 8,000 to 10,000 women

die from metastatic HER2 positive breast cancer each year, the FDA

said.

Xeloda, or capecitabine, is made by Switzerland's Roche Holding AG.

South San Francisco-based Genentech Inc. makes Herceptin, also known

as trastuzumab.

Eventually, Tykerb could be studied for use with Herceptin, said Dr.

Len Lichtenfeld, deputy chief medical officer of the American Cancer

Society. And Glaxo said it's studying Tykerb as a treatment for other

cancers.

"Some of those reports have been promising and others less so. But it

is too early to know which other cancers - if any - are going to

respond to this new drug," Lichtenfeld said.

Expanded use of Tykerb eventually could make it a blockbuster drug for

Glaxo, with annual sales approaching or exceeding $1 billion, analysts

have said.