Millennium submits two VELCADE sNDAs to FDA

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today announced that it has submitted two supplemental new drug applications (sNDAs) for VELCADE^® (bortezomib) for Injection to the U.S. Food and Drug Administration (FDA). The first application seeks to add a subcutaneous route of administration for VELCADE. The second application is for the use of VELCADE in combination with rituximab in patients with relapsed follicular non-Hodgkin lymphoma (NHL).

“We look forward to working with the FDA on both of these submissions.”

"These two applications represent our continued commitment to further the clinical understanding of VELCADE by enhancing its administration options as well as defining its utility in new cancers," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "We look forward to working with the FDA on both of these submissions."

Both supplements are based on results from clinical trials that were presented at the American Society of Hematology (ASH) annual meeting held December 4-7, 2010, in Orlando, Florida. The VELCADE subcutaneous pivotal trial findings were published in the online version of the Lancet Oncology on April 19.

VELCADE is currently approved for intravenous use only in patients with multiple myeloma and in patients with mantle cell lymphoma who have received at least one prior therapy, a sub-type of NHL. VELCADE has been used by more than 230,000 patients in more than 90 countries worldwide.

SOURCE Millennium: The Takeda Oncology Company