Iressa & pneumonia

Continuing reports from Japan now have recorded 81 deaths from interstitial pneumonia among non-small cell lung cancer patients treated with AstraZeneca plc's Iressa. With a PDUFA deadline upcoming for the EGFR inhibitor in the U.S., the FDA is not providing any hint about how it is incorporating these events into its thinking.

According to the company, 48,000 patients have been treated with Iressa worldwide, including about 18,000 in Japan. Thus far, the incidence of the lung complication is below 1%, which AZN (London, U.K.) said is not significantly different than that of other lung cancer drugs, and is lower than the rates associated with chemotherapy and radiation...