Millennium submits new Velcade applications

Millennium has submitted applications to the US Food and Drug Administration (FDA) seeking approval of two new indications for its injectable cancer drug Velcade (bortezomib).

The first application seeks approval of a subcutaneous route of administration for the drug, which is currently approved only as an intravenous therapy. The second seeks approval of Velcade in combination with rituximab for the treatment of relapsed follicular non-Hodgkin lymphoma (NHL).

Velcade, a proteasome inhibitor, was granted accelerated approval in the US in 2003 as a treatment for multiple myeloma. The drug was approved in the US in 2007 as a treatment for patients with mantle cell lymphoma, which is a sub-type of NHL, who have received at least one prior therapy.

The newly submitted supplemental new drug applications (sNDAs) were based on results from clinical trials that were presented at the American Society of Hematology (ASH) annual meeting in late 2010. The subcutaneous pivotal trial findings were also published in the online version of the Lancet Oncology earlier this month.