AstraZeneca's EGFR opportunity

The competitive landscape for EGFR inhibitors has changed following the FDA's refusal to file ImClone System Inc.'s BLA for its Erbitux anti-EGFR antibody to treat refractory colorectal cancer and IMCL's uncertainty that the company can adequately respond to the letter without running a new trial. As a result, AstraZeneca plc has found itself with the opportunity to be first to market.

IMCL was the first to submit a marketing application for an EGFR antagonist to treat cancer in the U.S. In addition, Erbitux had fast track designation in the indication, which could have put the product on the market as early as the middle of this year with partner Bristol-Myers Squibb Corp. (BMY, Princeton, N.J.)...