ExCellThera Reports the EC’s Conditional Approval of Zemcelpro for Haematological Malignancies
Shots:
- The EC has granted conditional approval to Zemcelpro in all 30 EEA states for adults with haematological malignancies needing ASCT after myeloablative conditioning, when no other suitable donor cells are available; regulatory filing is underway in the US, UK, Canada & Switzerland
- Zemcelpro availability will vary by country based on national reimbursement processes; meanwhile, Cordex Biologics (ExCellThera’s subsidiary) is collaborating with health authorities for early patient access, building a treatment center network, & pursuing strategic partnerships to drive commercialization in Europe & other regions
- Zemcelpro (UM171 Cell Therapy) is a personalized cryopreserved stem cell transplantation product comprising UM171-expanded CD34+ cells (dorocubicel) & unexpanded CD34− cells, both derived from the same cord blood unit; P-III trial for above pts to be initiated soon
Ref: Excellthera | Image: Excellthera| Press Release
Related News:- ExCellThera Reports CHMP’s Positive Opinion for Zemcelpro to Treat Haematological Malignancies
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