FDA GRANTS PRIORITY REVIEW TO MILLENNIUM'S NHL DRUG

The FDA has granted priority review to Millennium Pharmaceuticals' supplemental new drug application for Velcade for the treatment of relapsed mantle cell lymphoma, an aggressive, incurable subtype of non-Hodgkin's lymphoma (NHL) for which there is no current standard of care.

Priority review is granted to drugs that address an unmet medical need and would be a significant improvement in treatment compared with existing therapies. The FDA expedites the approval process for such an application and makes a decision within six months. Acceptance of the filing indicates the FDA has determined that the application is sufficiently complete to permit a substantive review.

The submission was based on final Phase II trial data that showed a 33 percent overall response rate and an 8 percent complete response rate. These results are similar to those of four investigator-initiated Phase II l trials where overall response rates of 30 to 40 percent with single-agent Velcade were established.