Deciphering the Velcade results

At first glance, the numerically low response rates and high adverse events rates in the Phase II trials of Velcade from Millennium Pharmaceuticals Inc. look worrisome, but viewing the data in the context of the multiple myeloma (MM) patients being treated presents a different picture. The study also has given the company reasons to believe that a pharmacogenomic approach eventually will help it identify responders prospectively.

Earlier this month, MLNM (Cambridge, Mass.) said it would file early next year for U.S. and European approval for Velcade bortezomib (LDP-341, PS-341), a small molecule dipeptide boronic acid proteasome inhibitor. Although a Phase III trial is ongoing, MLNM plans to seek accelerated approval based on the Phase II studies, which were presented last week at the American Society of Hematology (ASH) meeting in Philadelphia...