Takeda on Monday announced that the FDA approved a label update for Velcade (bortezomib) to include subcutaneous administration of the drug in all approved indications. "Subcutaneous Velcade is yet another advance in the management of patients with multiple myeloma (MM) or relapsed mantle cell lymphoma," commented Karen Ferrante, Chief Medical Officer of Takeda subsidiary Millennium.
The approval was based on results from a late-stage trial that randomised 222 bortezomib-naïve patients with relapsed MM to receive Velcade either subcutanously or intravenously. The trial met its primary objective of demonstrating that single agent subcutaneous Velcade retained at least 60 percent of the overall response rate (ORR) after 4 cycles relative to single agent intravenous use of the drug. Takeda noted that the overall safety profile was similar between the two arms, but 38 percent of patients given subcutaneous Velcade experienced periperhal neuropathy compared to 53 percent of patients in the intravenous arm.
Under the terms of a co-development agreement, Millennium is responsible for commercialisation of Velcade in the U.S., while Johnson & Johnson's Jannssen Pharmaceutical unit is responsible for commercialisation in Europe and the rest of the world, except in Japan where the drug is co-promoted with Takeda.