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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:

  • On April 18, 2017, Novartis announced that the FDA has granted Breakthrough Therapy designation to CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies. The Breakthrough Therapy designation is based on data from the multi-center Phase II JULIET study, which is evaluating the efficacy and safety of CTL019 in adult patients with r/r DLBCL. Findings from JULIET are expected to be presented at an upcoming medical congress. This marks the 14th Breakthrough Therapy designation for Novartis since the FDA initiated the program in 2013.
  • • On 6-8 September, 2016, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for  autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 for treatment of diffuse large B-cell lymphoma.
  • • On February 3, 2015, the FDA has granted orphan drug designation for tisagenlecleucel-T in the 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: 2015-02-03

Orphan status UE: 2016-10-14

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes