
ExCellThera announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on Zemcelpro.
The recommendation suggests granting conditional marketing authorisation for Zemcelpro, targeting adults with haematological malignancies in need of an allogeneic haematopoietic stem cell transplantation after myeloablative conditioning when no suitable donor cells are available.
The European Commission is anticipated to deliver a final decision within two months, impacting all 27 EU member states, Iceland, Norway, and Liechtenstein.
Zemcelpro, also referred to as UM171 Cell Therapy, is a cryopreserved haematopoietic stem cell transplantation product. It includes two components: UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, both sourced from the same cord blood unit.
If approved, Zemcelpro would become the first authorised therapy of its kind in the EU for adults with specific haematological malignancies lacking suitable donor cells.
Europe records over 10,000 new cases annually of patients with haematological malignancies, such as leukaemia’s and myelodysplastic syndromes, who require bone marrow transplants. Many of these patients face challenges in finding suitable donor cells due to various reasons, including the lack of suitably matched donors.
The positive CHMP opinion is based on Zemcelpro’s conditional marketing authorisation application (MAA). ExCellThera plans additional filings for Zemcelpro with health authorities in the US, Canada, the UK, and Switzerland.
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.”
Zemcelpro’s safety profile aligns with the established safety standards of conventional allogeneic blood stem cell transplantation for haematological malignancies following myeloablative conditioning.
ExCellThera CSO and founder Dr Guy Sauvageau said: “Each year, thousands of people in Europe are diagnosed with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation, and it’s an upsetting reality that a number of them don’t have access to suitable donor-derived stem cells.”