Takeda's Millennium files two sNDAs for Velcade with US FDA

Japan’s largest drugmaker, Takeda Pharmaceutical (TSE: 4502), together with its US oncology subsidiary Millennium, has submitted two supplemental New Drug Applications (sNDAs) for its myeloma treatment Velcade (bortezomib) for Injection to the US Food and Drug Administration.

The first application seeks to add a subcutaneous route of administration for Velcade. The second application is for the use of the drug in combination with rituximab in patients with relapsed follicular non-Hodgkin lymphoma (NHL).

“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, chief medical officer of Millennium, adding: “We look forward to working with the FDA on both of these submissions.”