Velcade Gets Priority Review for Mantle Cell Lymphoma

Millennium’s sNDA for Velecade for the treatment of relapsed mantle cell lymphoma (MCL) was granted Priority Review designation by the FDA. MCL is an aggressive, incurable subtype of non-Hodgkin’s lymphoma (NHL) for which there is no current standard of care. Priority Review is granted to compounds that address an unmet medical need and would be a significant improvement in treatment compared to existing therapies.

The sNDA submission was based on Phase II data from the PINNACLE study, which showed a 33% overall response rate and an 8% complete response rate. Significantly, the median duration of response was 9.2 months, and 13.5 months in patients who achieved a complete response. These results are similar to those of four investigator initiated Phase II trials where overall response rates of 30 to 40% with single-agent Velcade were established.