Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that Busulfex 60 mg for intravenous drip infusion has received regulatory approval in Japan for the additional medical indication as a conditioning regimen prior to autologous hematopoietic stem cell transplantation for patients with malignant lymphoma.

Busulfex (generic name: busulfan) is an injectable medicine that is used primarily as a conditioning agent prior to hematopoietic stem cell transplantation in patients with hematologic malignancies. It has received regulatory approvals in the U.S., Europe and Japan. Since its approval in Japan in 2006, Busulfex has been prescribed to many patients due to its efficacy as a conditioning regimen for allogeneic hematopoietic stem cell transplantation and an autologous stem cell transplantation in Ewing sarcoma family of tumors and neuroblastoma.

In response to a request for additional indications for Busulfex by medical societies to the Pharmaceutical Affairs and Food Sanitation Council's Second Committee, a committee meeting was held on October 31, 2019 regarding the efficacy of Busulfex in malignant lymphoma, and the evaluation was positive. A prior evaluation is required to pursue a public application.*

Otsuka filed an application for the additional indication in November 2019.

• A publicly known application for approval in one in which all or part of prior clinical trial data is accepted in the application, as the efficacy and safety of the drug are known in the medical and pharmacy professions.