VELCADE (formerly known as MLN341, LDP-341, and PS-341) is a novel drug candidate that may have broad applications in cancer. In January 2003, Millennium submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval to market VELCADE as a treatment for relapsed and refractory multiple myeloma. Additional studies of VELCADE as a single agent and in combination with other chemotherapeutic agents are continuing in a variety of different tumor types. These include a Phase III clinical trial in patients with multiple myeloma, and Phase I and II clinical trials in patients with other hematologic (blood) cancers or solid tumors.

VELCADE is designed specifically to inhibit proteasomes, which are enzyme complexes in all cells responsible for breaking down a variety of proteins, including many that regulate the cell cycle. Laboratory studies have suggested that by inhibiting the proteasome, VELCADE disrupted turnover of regulatory proteins in cancer cells and ultimately induced apoptosis, or programmed cell death.

For more detailed explanations of proteasomes and proteasome inhibitors, click here to access a video animation, or here to download a brochure (PDF).

VELCADE is the first proteasome inhibitor to enter clinical trials for the treatment of cancer. For more detailed clinical trial information about VELCADE, click here.

VELCADE has been granted fast-track designation by the FDA for refractory multiple myeloma. The FDA grants fast-track status to facilitate the development and expedite the review of an investigational drug if it is intended for the treatment of a serious life-threatening condition, and demonstrates the potential to address unmet medical needs for such a condition. VELCADE has also been granted Orphan Product Designation by the FDA. This designation is granted for treatments that may provide significant benefit to patients with serious life-threatening diseases that have a prevalence of no more than 200,000 patients in the U.S. Upon FDA approval of the product, Orphan Product Designation provides seven-year marketing exclusively in the U.S.