1 February 2019

TEPADINA®

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TEPADINA®, an alkylating agent used with other medicines in the conditioning regimen before hematopoietic stem cell transplantation, is ADIENNE’s currently marketed product commercialized in 42 countries.

Since its approval in the EU in 2010, TEPADINA®, for which ODD has been granted in the European Union, U.S. and Switzerland, has attained a key role in many conditioning regimens before autologous and allogeneic HSCT for treating myeloma, lymphomas, acute leukemia and other malignant and non-malignant haematological diseases as well as for the treatment of solid tumours.

Conditioning is a fundamental preparatory step for engrafting hematopoietic stem cell transplants in the patient’s marrow space and for controlling or eradicating the underlying disease. Bone marrow transplant, also called a stem cell transplant, is a procedure that infuses healthy cells, called stem cells, into a body to replace damaged or diseased bone marrow.

Bone marrow transplants may use cells from your own body (autologous trans-plant) or from a donor (allogeneic transplant). TEPADINA® can be used for both transplantations, autologous and allogeneic.

TEPADINA® is currently approved in the European Union, Switzerland, Israel, Russia, India and Hong Kong for use in in combination with other chemotherapy medicinal products:

– with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;

– when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.

In January 2017 TEPADINA® has been granted approval in the Unites States to reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia.

In March 2017 TEPADINA® has been granted approval in Canada for use in combination with other chemotherapeutic products as part of a high-dose chemotherapy (HDCT) consolidation regimen followed by autologous stem cell transplantation (ASCT) for adult patients with central nervous system (CNS) lymphoma.