Abbott Seeks FDA approval for cancer drug despite failed trials_WSJ

September 12, 2005

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org

FYI

Abbott Laboratories is asking the FDA to approve a cancer drug even

though it failed in clinical trials to demonstrate a benefit greater

than placebo--which is a minimal FDA requirement.

The Wall Street Journal reports: " Xinlay is central to Abbott's foray

into the lucrative cancer market and is the first drug in five years

to emerge from the company's own labs. Some analysts believe Xinlay

could reach about $1 billion in annual sales if approved. If Xinlay

fails, Abbott would be left with a big hole in its pipeline. "

If the FDA buckles under pressure and sets aside minimal efficacy

standards to accommodate Abbott, then all drug companies will demand

the same waiver for their drugs.

What possible public interest would be served if minimal standards of

drug efficacy are waived?

Do we need another worthless cancer drug on the market? Has the FDA

learned nothing from the debacle of Iressa?

If the preliminary data does not show a benefit--what is the basis

for speculating that additional data will alter those failed findings?

Have FDA officials learned nothring from the agency's fast-track

approval process that led to the marketing of lethal drugs--such as:

Vioxx / Propulsid / Baycol / FenPhen / Rezulin

A law is needed to protect the public from corporate predators and an

emasculated FDA.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

THE WALL STREET JOURNAL

Abbott Pushes Stalled Drug

Firm to Ask FDA to Approve Cancer Medicine Despite Failed Trials

By LEILA ABBOUD

September 12, 2005; Page B3

In a test of where the Food and Drug Administration is setting the

bar for approval of cancer drugs, Abbott Laboratories will ask the

agency to approve a drug for advanced prostate cancer that failed to

show effectiveness in two clinical trials.

The drug, a potential blockbuster for Abbott, aims to slow the spread

of prostate cancer to the bone in men who have failed to improve on

the hormone therapies used early in their treatment.

The Abbott Park, Ill., drug maker plans to make an unorthodox

argument that although the clinical trials of the drug, Xinlay,

didn't show with statistical significance that it slowed disease

progression better than a placebo, enough data exist to prove that

the drug has bioactivity and few side effects.

To that end, Abbott will present a retrospective analysis that

combines data from the two failed clinical trials of about 1,000 men.

It is unusual for a drug company to apply for regulatory approval

based on such a " pooled analysis " of data after it has been

collected. The highest-quality data come from placebo-controlled and

blinded studies in which the standards and hypotheses are set in

advance and unchanged until completion. Pooled analyses are more

problematic because they can introduce biases or lump together

dissimilar data.

A panel of outside advisers to the FDA will weigh the evidence behind

Xinlay tomorrow[9/13]. The cancer-drug advisory panel then votes on

whether the FDA should approve the drug, approve it with further

study required or reject it. The FDA usually follows the advice of

these panels but isn't required to do so.

The meeting will be closely watched by the industry and investors as

a gauge of the FDA's shifting attitudes on just how much evidence is

required for new cancer drugs to be approved. An FDA spokesman said

no changes had been made in policy on cancer drugs.

Federal law permits certain cancer drugs to be approved with a

somewhat lower threshold of efficacy evidence because of the need to

get treatments to dying patients. Such " accelerated approvals " permit

some cancer drugs to launch before the completion of later-stage

clinical trials, based on the strength of the early data and

requirements for further studies. The approach has come under fire

since a promising AstraZeneca PLC lung-cancer drug called Iressa was

allowed on the market in 2003 based on early clinical-trial data,

only to have later, large clinical trials show that Iressa doesn't

extend patients' lives.

Though Abbott isn't seeking accelerated approval for Xinlay, the lack

of definitive evidence that the drug actually works raises issues

similar to those about Iressa. The Iressa episode has already

affected other drug applications. When the cancer-advisory panel in

May voted against allowing a leukemia drug from & to

launch based only on early data, several members cited Iressa as a

cautionary tale.

Xinlay is central to Abbott's foray into the lucrative cancer market

and is the first drug in five years to emerge from the company's own

labs. Some analysts believe Xinlay could reach about $1 billion in

annual sales if approved. If Xinlay fails, Abbott would be left with

a big hole in its pipeline.

Unlike traditional chemotherapy to kill cancer cells, Xinlay aims to

slow the disease by blocking the effect of a protein called

endothelin. Endothelin is thought to play a role in the spread of

prostate cancer to bones. Xinlay's new mechanism made it more

difficult to test than a typical cancer-drug trial, in which

effectiveness is measured by tracking tumor shrinkage. Instead, a

composite measurement, including bone scans and changes in symptoms

like bone pain, was used.

Abbott has another study of Xinlay under way in men with less-

advanced prostate cancer. But Leonard, Abbott's vice president

of global medical and scientific affairs, said the company decided

not to delay its application to wait for these results. " We do

believe that there is convincing evidence that shows patients will

benefit from access to this drug, " he said.

Write to Leila Abboud at leila.abboud@...

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September 12, 2005