EU CHMP recommends approval of Zalmoxis in haploidentical haematopoietic stem cell transplantation- MoLMed
The EU's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Zalmoxis, from MoLMed, intended as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with high-risk haematological malignancies. As Zalmoxis is an advanced therapy medicinal product, the CHMP positive opinion is based on an assessment by the Committee for Advanced Therapies.
The benefits with Zalmoxis are its ability to increase overall survival rates: data in 45 patients treated with Zalmoxis showed that survival rate was 49% after one year with Zalmoxis, compared with data from databases of 140 patients who had undergone haploidentical HSCT without Zalmoxis, where survival rate was 37%. The most common side effect was acute graft-versus-host disease.
Comment: Zalmoxis will be available as dispersion for infusion. The active substance of Zalmoxis is made of allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor and the herpes simplex I virus thymidine kinase (HSV-TK Mut2).
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins