AstraZeneca says that it is withdrawing the European marketing application for its non small cell lung cancer agent, Iressa (gefitinib), after trial data last month revealed no overall survival benefit amongst patients taking the drug in a major clinical trial [[20/12/04b]]. In a statement, AZ said that these survival results did not meet approval requirements.
The Anglo-Swedish company is, however, keeping its options open and says that it will consider re-filing the drug with the European authorities in the future, after evaluating the trial’s full data set. Preliminary results were released late last month, showing no significant survival benefit in spite of a statistically significant improvement in tumour shrinkage (response rate) and time to treatment failure. AZ says that the status of all ongoing company-sponsored trials into NSCLC is under review, but it remains convinced that Iressa does provide some benefit in this condition.
The company says that discussions with regulators in the US and Japan, where the drug is already sold [[06/05/03a]], [[08/07/02b]], are ongoing, as are talks with all other regulatory authorities.
Iressa had been touted as a potential blockbuster drug for the company, so the latest news will no doubt prove another major blow for the firm, which has suffered a string of setbacks in recent months. US regulators recently rejected another potential top-earner for the firm – Exanta (ximelagatran) – and its cholesterol-lowerer, Crestor (rosuvastatin), has come under scrutiny in the USA after a Food and Drug Administration scientist questioned its safety [[22/11/04a]]. And Iressa has not been without controversy, having been linked to a serious side effect and having its efficacy questioned [[28/10/02a]], [[02/05/03a]].