Date: 2014-11-13
Type of information: Granting of the orphan status in the US
Product name: JCAR015 - autologous CD3+ T cells transduced with retroviral vector containing a chimeric antigen receptor directed against CD19 (Autologous CD3+ T cells containing CD19 chimeric antigen receptor)
Compound: autologous CD3+ T cells transduced with retroviral vector containing a chimeric antigen receptor directed against CD19 (Autologous CD3+ T cells containing CD19 chimeric antigen receptor)
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism: gene therapy/cell immunotherapy/CAR-T cell therapy. JCAR015 is based on chimeric antigen receptor technology. JCAR015 Phase I trials are currently underway at Juno's collaboration partner, Memorial Sloan Kettering Cancer Center.
Company: Juno Therapeutics (USA - WA)
Disease: acute lymphoblastic leukemia
Latest news: * On November 24, 2014, Juno Therapeutics announced that the FDA has granted Breakthrough Therapy Designation to the company's JCAR015 chimeric antigen receptor product candidate. The designation applies for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia and was filed by Juno's collaboration partner, Memorial Sloan Kettering Cancer Center, where Phase 1 clinical trials are currently underway.
* On November 13, 2014, the FDA has granted orphan drug designation for autologous CD3+ T cells transduced with retroviral vector containing a chimeric antigen receptor directed against CD19 (Autologous CD3+ T cells containing CD19 chimeric antigen receptor) for the treatment of acute lymphoblastic leukemia.
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:
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Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2014-11-13
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
