Zalmoxis

Withdrawn

This medicine's authorisation has been withdrawn

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)

Overview

On 9 October 2019, the European Commission withdrew the marketing authorisation for Zalmoxis (nalotimagene carmaleucel) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, MolMed S.p.A, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Zalmoxis (nalotimagene carmaleucel) was granted marketing authorisation in the EU on 18 August 2016 as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with high-risk haematological malignancies. This was a conditional marketing authorisation and was subsequently renewed yearly.

 The European Public Assessment Report (EPAR) for Zalmoxis (nalotimagene carmaleucel) is updated to indicate that the marketing authorisation is no longer valid.

Zalmoxis : EPAR - Summary for the public

Reference Number: EMA/454627/2016

Product information

Zalmoxis : EPAR - Product Information

Zalmoxis : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Zalmoxis
• 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)
• International non-proprietary name (INN) or common name:
  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)
• Therapeutic area (MeSH):
  • Hematopoietic Stem Cell Transplantation
  • Graft vs Host Disease
• Anatomical therapeutic chemical (ATC) code:
  L01

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Zalmoxis is indicated as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with high-risk haematological malignancies.

Authorisation details

• EMA product number:
  EMEA/H/C/002801
• Advanced therapy:

  This medicine is classified as an advanced therapy medicinal product (ATMP): a medicine for human use that is based on genes, tissues or cells. It offers groundbreaking new opportunities for the treatment of disease and injury. For more information, see Advanced therapy medicinal products: Overview.

• Conditional approval:

  This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

• Marketing authorisation holder:
  MolMed SpA

  Via Olgettina 58 ; 20132 Milan ; Italy

• Opinion adopted:
  23/06/2016
• Marketing authorisation issued:
  18/08/2016
• Revision:
  1

Assessment history

Changes since initial authorisation of medicine

Zalmoxis : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Zalmoxis : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/589978/2016

CHMP summary of opinion for Zalmoxis

Adopted Reference Number: EMA/CHMP/380467/2016