ExCellThera Reports CHMP’s Positive Opinion for Zemcelpro to Treat Haematological Malignancies
Shots:
- The CHMP has recommended conditional approval of Zemcelpro in 30 EEA states for adults with haematological malignancies requiring allogeneic HSCT after myeloablative conditioning with no suitable donor; EC’s decision is expected within 2mos.
- Zemcelpro (UM171 Cell Therapy) was evaluated in P-II trials for pts with high & very high-risk acute leukemias & myelodysplasias with limited therapy options & poor outcomes with SoCs, incl. those with TP53 mutations, refractory/active disease, or who require another transplant
- Zemcelpro will be advanced in a P-III trial for mentioned pts, plus additional filings are planned in multiple regulatory bodies incl. the US, Canada, the UK, & Switzerland
Ref: Prnewswire | Image: Excellthera| Press Release
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