Table 2.
Overview on ATMPs with past/present marketing authorisation.
| Name | Authorisation holder | Indication | Authorisation number | Approval date | Status |
|---|---|---|---|---|---|
| Yescarta® | Kite Pharma | B-cell lymphoma | EMEA/H/C/004480 | 08/2018 | APPROVED |
| Kymriah® | Novartis | ALL, DLBCL | EMEA/H/C/004090 | 08/2018 | APPROVED |
| Alofisel® | TiGenix | Perianal fistulas in Crohn´s disease | EMEA/H/C/004258 | 03/2018 | APPROVED |
| Spherox® | CO.DON | Cartilage defects in the knee joint | EU/1/17/1181 | 05/2017 | APPROVED |
| Zalmoxis® | MolMed | Stem cell transplantation in high-risk blood cancer | EMEA/H/C/002801 | 06/2016 | APPROVED |
| Strimvelis® | GSK | ADA-SCID | EU/1/16/1097 | 04/2015 | APPROVED |
| Imlygic® | Amgen | Melanoma | EU/1/15/1064 | 09/2015 | APPROVED |
| Holoclar® | Chiesi | Severe limbal stem cell deficiency in the eye | EU/1/14/987 | 03/2015 | APPROVED |
| Provenge® | Dendreon | Metastatic prostate cancer | EMEA/H/C/002513 | 10/2013 | withdrawn in 2015 |
| MACI | Vericel | Cartilage defects in the knee joint | EU/1/13/847 | 07/2013 | withdrawn in 2014 |
| Glybera® | Uniqure | Lipoprotein Lipase Deficiency | EU/1/12/791/001 | 11/2012 | withdrawn in 2017 |
|
Chondro Celect® |
TiGenix | Cartilage defects | EMEA/H/C/000878 | 11/2009 | withdrawn in 2016 |
ALL … Acute Lymphoblastic Leukaemia
DLBCL … Diffuse Large B Cell Lymphoma
ADA-SCID … Adenosine Deaminase Severe Combined Immunodeficiency