Trials and Tribulations

2006-10-03T07:38:00.000-07:00

Iressa's Trials and Tribulations

A few months after the drug was approved in

Japan

(in July 2002, following a whirlwind five-month review) to treat non-small cell lung cancer (NSCLC), reports surfaced of dozens of unusual deaths, mostly as a result of interstitial pneumonia. To date, more than 25,000 Japanese patients have received the drug and more than 200 of them have died from pneumonia-like illness.

Iressa could command a quarter of the annual lung cancer market worth about $2 billion per year, according to analysts.

Several factors could account for Iressa's mediocre Phase III results, including delivering the optimum dose of the drug to the tumor, and negative interactions when co-administered with other drugs. Moreover, EGFR inhibitors may simply not work in all tumors.

The mortality rate of about 1 percent among Japanese patients taking Iressa should be considered against the fact that lung cancer claims more than 50,000 lives in that country each year. But while the investigation into the cause of the fatal lung disease continues, this summer a Japanese health ministry panel declined to endorse Iressa. In spite of numerous studies that have deemed the drug effective, the panel concluded there were insufficient data to recommend it.

The mood was summed up by an editorial in The Japan Times: "When it comes to medicine, the bottom line is simple. Use of drugs that carry a high risk of causing harmful side effects must not be allowed ... The government, pharmaceutical companies, and doctors must respect this standard and promote anti-cancer drug treatment that benefits patients."

Fatal Side Effects

2006-10-03T07:34:00.000-07:00

Study Links Cancer Drug Iressa to Potential Fatal Side Effects
Source: Reuters: August 25, 2004 Legal News Watch

Cancer drug Iressa has a higher rate of a potentially fatal effect than what was demonstrated in an ealier study, AstraZeneca said last week.

*A new 10-month study involving 3,322 lung cancer patients found 5.8% of them suffered interstitial pneumonia within eight weeks of starting treatment with Iressa, with a mortality rate of 2.3% due to pneumonia*, Reuters reported.

Iressa has been linked to the death of 444 patients worldwide. The majority of the reports of incidence of interstitial peneumonia have occured in patients taking Iressa in Japan.