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How To Save A Drug: Iressa’s Return Relied On Consistency Across Totality Of Evidence

 
• By Bridget Silverman

Drug Review Profile of the second life of AstraZeneca’s Iressa shows how FDA adapts to imperfect but improving information without putting undue burden on sponsors – and how the agency recently applied a similar iterative approach to another EGFR inhibitor, Astellas and Genentech’s Tarceva.

FDA met the unusual circumstances of AstraZeneca PLC’s Iressa (gefitinib) in a genetically defined non-small cell lung cancer population – a new frontline NDA for a withdrawn third-line product – with an unconventional approach to the evidence, agency review documents show. Faced with a circumstance where the gold standard of two well-designed randomized trials would not be forthcoming, FDA looked for consistency of signals across an accretion of data.

Reviewers recognized problems with the trials underlying Iressa’s approval for first-line treatment of metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 substitution mutations, but the agency was convinced by mutually

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