Date: 2017-04-18
Type of information: Granting of the Breakthrough Therapy status
Product name: CTL019 (tisagenlecleucel-T)
Compound: autologous T Cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism: immunotherapy product/cell therapy/gene therapy/CAR-T cell therapy. CTL019 - tisagenlecleucel-T uses CAR technology to reprogram a patient's own T cells to "hunt" cancer cells that express specific proteins, called CD19. After they have been reprogrammed, the T cells (now called CTL019) are re-introduced into the patient's blood; they proliferate and bind to the targeted CD19+ cancer cells and destroy them. These autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 were previously known as CART19. CTL019 was first developed by the University of Pennsylvania (Penn). In 2012, Novartis and Penn have an exclusive global agreement to research, develop and commercialize personalized CAR T cell therapies for the treatment of cancers. Novartis holds the worldwide rights to CARs developed through the collaboration for all cancer indications, including the lead program CTL019.
Company: Novartis (Switzerland)
Disease: diffuse large B-cell lymphoma, relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies
Latest news:
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: 2015-02-03
Orphan status UE: 2016-10-14
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news: