Abbott Seeks FDA approval for cancer drug despite failed trials – WSJ

Mon, 12 Sep 2005

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

Abbott Pushes Stalled Drug
Firm to Ask FDA to Approve Cancer Medicine Despite Failed Trials
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 Johnson & Johnson 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 John 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.

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