Dorocubicel: First Approval.

Dorocubicel (Zemcelpro) is a cell therapy that includes UM171-expanded CD34 haematopoietic stem cells derived from umbilical cord blood. It is being developed by Cordex Biologics for the treatment of haematological malignancies and non-malignant haematological disorders. In patients with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation (HSCT), transplantation with dorocubicel has been shown to result in neutrophil and platelet engraftment, as well as rapid T cell reconstitution. This article summarizes the key milestones in the development of dorocubicel leading to this first approval for the treatment of adult patients with haematological malignancies who require an allogeneic HSCT following myeloablative conditioning, for whom no other type of suitable donor cells is available.