- TOKYO (Reuters) - Japan's
Health Ministry said on Thursday it has received reports of 81 deaths among
cancer patients linked to use of new lung cancer drug Iressa.
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- The drug is made by AstraZeneca Plc, which is Europe's
second-largest drug maker, and has so far only been used in Japan, where
it was released in July for treatment of non-small-cell lung cancer.
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- The death toll, as of November 25, compares with the
ministry's announcement in October of 13 deaths linked to Iressa.
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- The ministry said Iressa is not being withdrawn from
the market but it plans to have experts study the cases of patients who
have died or suffered side effects, and ask them to try to report back
by the end of this month.
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- "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.
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- AstraZeneca said in early November it could not rule
out a link between Iressa and interstitial pneumonia, a serious lung disease,
but it remained confident about Iressa's overall safety profile.
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- 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.
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- "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.
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- By November 25, the ministry had confirmed 291 cases
of debilitating side effects among patients using Iressa, who totaled 17,000.
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- STRONGER WARNINGS
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- It ordered AstraZeneca in October to issue stronger warnings
on the possibility that Iressa may cause interstitial pneumonia.
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- Iressa is the first in a new class of "smart bomb"
cancer drugs called epidermal growth factor receptor inhibitors that target
proteins produced only by cancer cells, so they do not cause the nausea
and hair loss associated with chemotherapy.
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- Regulators in the United States and Europe are currently
evaluating the drug, one of a number of new products that AstraZeneca hopes
will revitalize its product pipeline in the next few years.
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- AstraZeneca's global product director, Linda Summerton,
told an analysts' meeting on November 7 that interstitial pneumonia was
also associated with other cancer treatments. AstraZeneca was checking
links between the condition and Iressa but the rare cases did not alter
confidence in the medicine, she said.
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