Table 8.
The implementation of PMS for the CGTPs approved in the US
| Name | REMS | Black box warning | PMR | PMC |
|---|---|---|---|---|
| Fidanacogene elaparvovec-dzkt [168] | No | No | 0 | 0 |
| Atidarsagene autotemcel [169] | No | No | 2 | 0 |
| Lifileucel [170] | No | Yes | 0 | 1 |
| Exagamglogene autotemcel (exa-cel) [171] | No | No | 3 | 0 |
| Lovotibeglogene autotemcel (lovo-cel) [172] | No | Yes | 2 | 0 |
| Donislecel-jujn [146] | No | No | 0 | 0 |
| Valoctocogene roxaparvovec-rvox [147] | No | No | 0 | 0 |
| Delandistrogene moxeparvovec-rokl [148] | No | No | 1 | 1 |
| Beremagene geperpavec [149] | No | No | 0 | 0 |
| Nadofaragene firadenovec-vncg [150] | No | No | 0 | 1 |
| Etranacogene dezaparvovec-drlb [151] | No | No | 2 | 0 |
| Elivaldogene autotemcel [152] | No | Yes | 5 | 0 |
| Betibeglogene autotemcel [153] | No | No | 2 | 0 |
| Ciltacabtagene autoleucel [154] | Yes | Yes | 1 | 0 |
| Allogeneic processed thymus tissue–agdc [155] | No | No | 0 | 0 |
| Allogeneic cultured keratinocytes and dermal fibroblasts in murine [156] | No | No | 1 | 0 |
| Idecabtagene vicleucel [157] | Yes | Yes | 1 | 1 |
| Lisocabtagene maraleucel [158] | Yes | Yes | 1 | 0 |
| Brexucabtagene autoleucel [159] | Yes | Yes | 3 | 0 |
| Onasemnogene abeparvovec [160] | No | Yes | 0 | 0 |
| Tisagenlecleucel [161] | Yes | Yes | 1 | 0 |
| Voretigene neparvovec-rzyl [162] | No | No | 0 | 0 |
| Axicabtagene ciloleucel [163] | Yes | Yes | 1 | 0 |
| Autologous cultured chondrocytes on a porcine collagen membrane [164] | No | No | 1 | 0 |
| Talimogene laherparepvec [165] | No | No | 1 | 0 |
| Allogeneic cultured keratinocytes and fibroblasts in bovine collagen [166] | No | No | 1 | 0 |
| Sipuleucel-T [167] | No | No | 0 | 0 |
| Total | 6 | 10 | 29 | 4 |