Sumitomo Dainippon applies to bring back thiotepa in Japan

Osaka’s Sumitomo Dainippon Pharma has submitted a new drug application in Japan for its candidate DSP-1958 (thiotepa), as a conditioning treatment prior to autologous hematopoietic stem cell transplantation (HSCT) for pediatric solid tumors.

The drug has been in use for many decades, marketed originally in Japan as Tesupamin, but has not been available in the country since 2009, when the active ingredient stopped being produced. In Europe, the product is marketed as Tepadina by German firm Riemser.

The firm says that, in spite of the discontinuation of its marketing in 2009 in Japan, “many requests for their use for this indication were made by academic societies and other parties concerned, as thiotepa was approved for conditioning treatment prior to HSCT in Europe in 2010.”