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news.The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of conditional marketing authorisation for ExCellThera's cryopreserved haematopoietic stem cell transplantation product, Zemcelpro.
The therapy comprises two components derived from the same cord blood unit. Credit: Louis Reed on Unsplash.
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The therapy is intended to treat the adult population with haematological malignancies needing an allogeneic haematopoietic stem cell transplantation after a myeloablative conditioning for those individuals with no other compatible donor cells type is available.
The European Commission (EC) is anticipated to decide on the committee’s recommendation within the next two months.
If approved, the authorisation will extend to all Member States of 27 European Union (EU) as well as Norway, Liechtenstein, and Iceland.
Also referred to as UM171 Cell Therapy, zemcelpro comprises two components derived from the same cord blood unit: UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells.
This potential approval is anticipated to address a critical need for more than 10,000 new patients in Europe annually who need bone marrow transplants for conditions such as leukaemia and myelodysplastic syndromes but lack access to compatible donor cells.
The positive opinion from CHMP is based on the conditional marketing authorisation application (MAA) for the therapy, with further filings planned with health authorities in Canada, the UK, Switzerland, and the US.
The safety profile of the therapy aligns with that of conventional allogeneic blood stem cell transplantation for haematological malignancies after myeloablative conditioning.
ExCellThera’s wholly owned subsidiary Cordex Biologics has developed the therapy, which has undergone assessment in 120 individuals in studies across Europe, Canada, and the US.
ExCellThera CEO David Millette said: “With today’s positive opinion, we are closer to bringing the life-changing potential of Zemcelpro to patients with at-risk haematological malignancies in the EU.
“We are proud to bring our transformative cell therapy innovation to patients who continue to have unmet medical needs.”
