The FDA has requested a label change for AstraZeneca's Iressa, to be implemented in September 2005.

June 22 2005: AstraZeneca's Iressa will only be available to patients who have previously demonstrated clinical benefit following the FDA's move to alter the drug's labeling. AstraZeneca is in desperate need of good news to offset its recent disappointments, with Exanta failing to gain US approval and Crestor under renewed criticism over its safety profile.

AstraZeneca withdrew its European Marketing Authorisation Application for Iressa following failure of the ISEL trial to demonstrate survival benefit in non-small cell lung cancer. This latest setback in the US will cast doubt over Iressa's (gefitinib) future prospects, and comes on top of AstraZeneca's recent problems over Exanta (ximelagatran) and Crestor (rosuvastatin).

The change in labeling now states that Iressa will only be available to patients who have previously shown clinical benefit. There are currently 4,000 patients in the US on Iressa, but the poor prognosis of this population suggests that this number will decline rapidly in the coming years.

Iressa is currently approved in 36 countries. This modified US approval is for use as monotherapy for the continued treatment of patients with locally advanced or metastatic non-small cell lung cancer, after failure of both platinum-based and docetaxel chemotherapies, who are benefiting, or have benefited from Iressa.

Iressa has now undoubtedly lost its ground in its battle with Tarceva (erlotinib), produced by Genentech, OSI and Roche. Both are small molecule, epidermal growth factor receptor tyrosine kinase inhibitors. During clinical trials, Tarceva showed an improvement in survival of refractory patients, from 4.7 months to 6.7 months when compared to placebo. Tarceva is now in a very strong market position.

Iressa, already launched in Japan and the US, represented one of AstraZeneca's top growth drivers, with global sales of $295 million in 2004, therefore this news is a significant blow for the company. However, AstraZeneca can take some consolation from sales of Iressa in Japan, where as yet there have been no restrictions placed on the drug's approval status since it was licensed: Japan accounted for $139 million of Iressa's total sales in 2004.

Source: Datamonitor CommentWire

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