publication date: Jul. 17, 2015

Iressa Returns to U.S. Market— Now with Companion Diagnostic 


FDA approved Iressa (gefitinib) for patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

The drug is being approved concurrently with the therascreen EGFR RGQ PCR Kit as a companion diagnostic.

Iressa is sponsored by AstraZeneca and therascreen by QIAGEN N.V.

In the U.S., therascreen has been marketed since 2013 as a companion diagnostic for the Boehringer-Ingelheim agent Gilotrif (afatinib).

Iressa is now approved for the same indication as Gilotrif.

Iressa’s July 13 approval is the case of science catching up with the drug. Iressa, the first EGFR inhibitor to get on the market, first received an accelerated approval in 2003, but was placed in a restricted access program two years later, after a confirmatory trial failed to demonstrate a survival advantage.

Iressa was first approved for third-line NSCLC, without differentiation for any specific mutation—since at that time it was unknown whether the existence of the mutation predicted a response (The Cancer Letter, May 9, 2002). And, of course, there was no diagnostic.

The drug squeaked through the approval process with an accelerated approval based on data from phase II trials showing 13.6 percent of U.S. patients achieved tumor shrinkage of at least 50 percent, after their disease had progressed, following failure of both platinum-based … Continue reading 41-28 Iressa Returns to U.S. Market— Now with Companion Diagnostic

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