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Drug Name:nalotimagene carmaleucel
Regulatory Designations: Breakthrough Therapy; Orphan Drug    
Originator Company: Istituto Scientifico H San Raffaele Active Companies: Istituto Scientifico H San Raffaele; MegaPharm Ltd; MolMed SpA; TTY Biopharm Co Ltd
Last Change Date: 2019-03-29

extract

conditional marketing authorization (CMA) was granted as a patient-specific adjunctive treatment in haplo-identical haematopoietic stem-cell transplantation (HSCT) for adults with high-risk hematological malignancies [ 1794144 ]. By November 2018...suspended the program due to other higher priority projects and a change in Japanese policy on HLA mismatched hematopoietic stem cell transplantation. Takara would wait for the EMA's review of the MAA to develop a more effective project plan [ 1586171


Other Drug Names:

HSV thymidine kinase gene therapy (GvH, retroviral vector), Istituto Scientifico H San Raffaele; HSV-TK; HSV-TK gene therapy (haematological malignancies), MolMed/Takara Bio; HSV-TK suicide gene therapy, MolMed/Takara Bio; TBI-0301; TBI-1101; TK cell therapy (haploidentical haematopoietic stem cell transplantation ), MolMed/Takara Bio; TK gene/cell therapy (bone marrow transplantation-associated GvHD prevention), MolMed/Takara Bio; TK-DLI, San Raffaele/MolMed/Takara Bio; TK-expressing donor T-cells (bone marrow transplantation-associated GvHD prevention), San Raffaele/MolMed; Zalmoxis; herpes simplex thymidine kinase suicide gene therapy, MolMed/Takara Bio; nalotimagene carmaleucel; thymidine kinase expressing donor T-cells (bone marrow transplantation-associated GvHD prevention), San Raffaele/MolMed/Takara

Technologies

Biological therapeutic; Cell therapy; Infusion; Intravenous formulation; T-lymphocyte

Development Status (Current)

Istituto Scientifico H San Raffaele: Italy: Phase 3 Clinical: Graft versus host disease: 09-Jun-2008 Dompe Farmaceutici SpA: Europe: Discontinued: Graft versus host disease: 12-Nov-2018 MegaPharm Ltd: Israel: Discovery: Graft versus host disease: 28-Apr-2017 TTY Biopharm Co Ltd: Hong Kong: Discovery: Graft versus host disease: 30-Jun-2017 TTY Biopharm Co Ltd: Taiwan: Discovery: Graft versus host disease: 30-Jun-2017 TTY Biopharm Co Ltd: South East Asia: Discovery: Graft versus host disease: 30-Jun-2017 Takara Bio Inc: Japan: Discontinued: Graft versus host disease: 31-Mar-2016 Takara Bio Inc: South Korea: Discontinued: Graft versus host disease: 31-Mar-2016 MolMed SpA: EU: Registered: Graft versus host disease: 22-Aug-2016 MolMed SpA: Israel: Phase 2 Clinical: Graft versus host disease: 30-Sep-2002 MolMed SpA: US: Phase 3 Clinical: Graft versus host disease: 18-Oct-2013

Development Status (History)

MolMed SpA: Germany: Phase 2 Clinical: Graft versus host disease: 30-Sep-2002 MolMed SpA: Greece: Phase 2 Clinical: Graft versus host disease: 30-Sep-2002 MolMed SpA: Italy: Phase 2 Clinical: Graft versus host disease: 30-Sep-2002 MolMed SpA: UK: Phase 2 Clinical: Graft versus host disease: 30-Sep-2002 MolMed SpA: Italy: Discovery: Graft versus host disease: 29-Dec-2002 Takara Bio Inc: Asia: Discovery: Graft versus host disease: 12-Feb-2003 Istituto Scientifico H San Raffaele: Italy: Clinical: Graft versus host disease: 05-Jun-2005 MolMed SpA: Italy: Phase 3 Clinical: Graft versus host disease: 09-Jun-2008 Takara Bio Inc: Japan: Phase 1 Clinical: Graft versus host disease: 31-Oct-2008 Takara Bio Inc: South Korea: Discovery: Graft versus host disease: 25-Feb-2013 MolMed SpA: EU: Pre-registration: Graft versus host disease: 07-Mar-2014 Takara Bio Inc: Japan: Suspended: Graft versus host disease: 05-Aug-2014 Takara Bio Inc: South Korea: Suspended: Graft versus host disease: 05-Aug-2014 Dompe Farmaceutici SpA: Europe: Discovery: Graft versus host disease: 25-Jul-2017

Drug Development Phase

[Graft versus host disease: Phase 3 Clinical: Italy Graft versus host disease: Discontinued: Europe Graft versus host disease: Discovery: Israel Graft versus host disease: Discovery: Hong Kong Graft versus host disease: Discovery: Taiwan Graft versus host disease: Discovery: South East Asia Graft versus host disease: Discontinued: Japan Graft versus host disease: Discontinued: South Korea Graft versus host disease: Registered: EU Graft versus host disease: Phase 2 Clinical: Israel Graft versus host disease: Phase 3 Clinical: US]

Therapy Area:

Immune


Highest Status

Registered


Target-based Actions

Thymidine kinase modulator


Other Actions

Blood system agent; Immunosuppressant


Active Indications

Graft versus host disease