Date: 2016-12-16
Type of information: Granting of the Breakthrough Therapy status
Product name: JCAR017 (lisocabtagene maraleucel)
Compound: CD19 specific CAR T cells also expressing an EGFRt
Therapeutic area: Cancer - Oncology
Action mechanism:
- cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy. JCAR017 is a CD19-specific CAR T cell therapy. It uses a defined CD4:CD8 cell composition and 4-1BB as the costimulatory domain, which differentiates it from other CD19-directed CAR T product candidates in clinical development.
Company: Juno Therapeutics (USA - WA)
Disease:
- relapsed/refractory (r/r) aggressive large B-cell non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma or grade 3B follicular lymphoma
Latest news:
- • On December 20, 2016, Juno Therapeutics announced that the FDA has granted Breakthrough Therapy designation to JCAR017 for the treatment of patients with relapsed/refractory (r/r) aggressive large B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, not otherwise specified (de novo or transformed from indolent lymphoma), primary mediastinal B-cell lymphoma or grade 3B follicular lymphoma. In addition, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) have granted JCAR017 access to the Priority Medicines (PRIME) scheme for r/r 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
