BRIEF—Sumitomo Dainippon files for additional indication on Rethio

Japanese drugmaker Sumitomo Dainippon Pharma today announced that on March 29 the company applied for a partial change in the marketing approval previously acquired in Japan for Rethio (thiotepa) 100mg for IV infusion.

The change applied for this time involves an additional indication of Rethio for conditioning treatment prior to autologous hematopoietic stem cell transplantation (auto-HSCT) for malignant lymphoma.

Rethio is a drug indicated for conditioning treatment prior to auto-HSCT for pediatric malignant solid tumors.

Sumitomo Dainippon obtained the marketing approval for this drug on March 26, 2019 and plans to launch it after NHI drug price listing.