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PLC’s Iressa (gefitinib) in a genetically defined non-small cell lung cancer population – a new frontline NDA for a withdrawn third-line product – with an unconventional approach to the evidence, agency review documents show.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...
FDA’s decision was “based on the totality of the evidence,” Division of Oncology Products 2 Director Patricia Keegan explained in her July 13, 2015 summary review. The pivotal trial, IFUM,...