AstraZeneca’s Iressa, Now Resurrected, Faces Daunting U.S. EGFR Market

AstraZeneca PLC has big ambitions for the reintroduction of the EGFR inhibitor Iressa as a springboard for a lung cancer franchise in the U.S., but is likely to face an uphill battle given how long the drug has been off the market and how entrenched Roche/Astellas Pharma Inc.’s Tarceva has become.

FDA’s approval of Iressa (gefitinib) for first-line treatment of metastatic non-small cell lung cancer with EGFR mutations was announced on July 13