Japan Links 81 Deaths to new Lung Cancer Drug

Japan Links 81 Deaths to new Lung Cancer Drug

Thu, 5 Dec 2002

Now a days, the fate of a drug depends not so much on its efficacy and safety, but rather on the financial needs of the manufacturer and the company’s ability to round up an “independent” panel of experts to give the drug a passing grade.

In Japan, the only country in which AstraZeneca Plc’s new lung cancer drug, Iressa, has been launched, ABC reports that there have been 291 confirmed cases of debilitating side effects among patients whose number totaled 17,000– and the drug has been linked to 81 deaths since July.

However,”Analysts at Lehman Brothers…said the deaths might not present a barrier to Food and Drug Administration approval, since patients on the drug were already terminally ill.”

One is led to wonder what adverse events do “present a barrier” to FDA approval!

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Japan Links 81 Deaths to New Lung Cancer Drug
Dec. 5
By Yuka Obayashi

TOKYO (Reuters) – Japan’s Health Ministry said on Thursday it had received reports of 81 deaths among cancer patients linked to use of AstraZeneca Plc’s new lung cancer drug Iressa.

Iressa has so far only been launched in Japan, where it went on sale in July for treatment of non-small-cell lung cancer, but the firm hopes to win approval in the all-important U.S. market before the end of the year.

Industry analysts said the latest deaths were unlikely to derail Iressa’s launch in the United States and Europe, although it would add to uncertainty over its uptake among clinicians.

The latest death toll, up to November 25, compares with a ministry announcement in October of 13 deaths linked to Iressa, one of a number of drugs AstraZeneca hopes will help revitalize sales following the decline of ulcer pill Losec.

The ministry said Iressa was not being withdrawn from the market but it plans to have experts study the cases of patients who had died or suffered side effects and ask them to try to report back by the end of this month.

“The drug has proven effective for some patients, and the cases where there have been side effects do not rule out its efficacy,” said Tatsuo Kurokawa, the ministry official who oversees safety of drugs.

AstraZeneca, Europe’s second-biggest drugmaker, has said it cannot rule out a link between Iressa and interstitial pneumonia, a serious lung disease, which it said was also associated with other cancer treatments.

However, the firm said in a statement late on Thursday that an independent group of drug safety experts and lung specialists which it had convened in Japan to study the issue had concluded that the clinical benefits of Iressa outweighed the risks.

A company spokeswoman said less than one percent of 48,000 patients who had received Iressa in clinical trials and in treatment in Japan had developed interstitial pneumonia.

She said the condition was a well-known complication of lung cancer, reported in up to five percent of patients treated with chemotherapy and 11 per cent of those who received radiotherapy.

WAITING FOR THE FDA

Analysts at Lehman Brothers, who forecast only modest peak sales of $325 million a year for Iressa, said the deaths might not present a barrier to Food and Drug Administration approval, since patients on the drug were already terminally ill.

“However, it adds uncertainty to the stock with regard to the full approval of Iressa in the U.S. and possible restriction of Iressa use in Japan,” they said in a note.

Shares in AstraZeneca closed 2.1 percent weaker at 23.56 pounds, underperforming a European drugs sector that was down 1.2 percent.

The ministry said it had been investigating the link between Iressa and the side effects, but that it had not been able to reach a conclusion since the drug is used by cancer patients who cannot be operated on or whose cancer is recurring.

“We will continue to monitor the side effects of the new cancer drug as well as continue to call for the proper usage of the drug by medical institutions,” Kurokawa said.

By November 25, the ministry had confirmed 291 cases of debilitating side effects among patients using Iressa, who totaled 17,000.

It ordered AstraZeneca in October to issue stronger warnings on the possibility that Iressa may cause interstitial pneumonia.

Iressa is the first in a new class of “smart bomb” cancer drugs called epidermal growth factor receptor inhibitors. They target proteins produced only by cancer cells and do not cause the nausea and hair-loss associated with chemotherapy.

Regulators in the United States and Europe are currently evaluating the drug, one of a number of new products that AstraZeneca hopes will revitalise its product pipeline in the next few years.

(Additional reporting by Ben Hirschler and Richard Woodman in London)

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