Products

Date: 2017-06-15

Type of information: Positive opinion for the granting of the orphan status in the EU

Product name: autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor

Compound: autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor

Therapeutic area: Cancer - Oncology - Rare diseases

Action mechanism: cell therapy/immunotherapy product/gene therapy.

Company: Celgene (USA - NJ)

Disease: diffuse large B-cell lymphoma

Latest news:

• On June 15, 2017, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor for treatment of diffuse large B-cell lymphoma.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes