Zalmoxis (allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2))
ATMPConditional
- Region
- 🇪🇺 EU
- Active substance
- allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)
- Company
- MolMed SpA
- Status
- Withdrawn
- Therapeutic area
- Hematopoietic Stem Cell Transplantation; Graft vs Host Disease
- CHMP opinion
- Thu 23 Jun 2016
- EU approval
- Thu 18 Aug 2016
- Designations
- ATMP, Conditional
- Application
- EMEA/H/C/002801
- ATC
- L01
- Official record
- www.ema.europa.eu
Indication
Zalmoxis is indicated as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with high-risk haematological malignancies.
Regulatory milestones
No milestones recorded in the last year.
Follow Zalmoxis
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.