Novartis Receives FDA Breakthrough

Novartis CAR-T cell therapy CTL019 receives FDA breakthrough therapy designation for treatment of adult patients with r/r DLBCL

  • Designation prioritises investigational CTL019 (tisagenlecleucel) as a potential treatment for adult patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL)
  • R/r DLBCL, an aggressive cancer with limited options, is the second indication for CTL019 to receive Breakthrough Therapy designation
  • Advances in CTL019 result from collaboration with the University of Pennsylvania; regulatory submissions for r/r DLBCL are expected to be filed by the end of the year

Novartis has announced that the US Food and Drug Administration (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. This is the second indication for which CTL019 has received this designation; the first being for the treatment of r/r B-cell acute lymphoblastic leukaemia (ALL) in paediatric and young adult patients.

“At Novartis, we are eager to unlock the full potential of CTL019, including the potential to help patients with r/r DLBCL,” said Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer, Novartis. “We look forward to working closely with the FDA to help bring this potential new treatment option to patients as soon as possible.”

CAR-T cell therapy is different from typical small molecule or biologic therapies currently on the market because it is manufactured for each individual patient. During the treatment process, T cells are drawn from a patient’s blood and reprogrammed in the laboratory to create T cells that are genetically coded to hunt the patient’s cancer cells and other B-cells expressing a particular antigen.

CTL019 was first developed by the University of Pennsylvania (Penn). In 2012, Novartis and Penn entered into a global collaboration to further research, develop and then commercialise CAR-T cell therapies, including CTL019, for the investigational treatment of cancers. Through the collaboration, Novartis holds the worldwide rights to CARs developed with Penn for all cancer indications. In March 2017, Novartis announced that the FDA accepted the company’s Biologics License Application filing and granted priority review for CTL019 in the treatment of r/r paediatric and young adult patients with B-cell ALL.

The Breakthrough Therapy designation is based on data from the multi-center Phase II JULIET study (NCT02445248), which is evaluating the efficacy and safety of CTL019 in adult patients with r/r DLBCL. JULIET is the second global CAR-T trial, following the Novartis ELIANA study (NCT02435849) investigating CTL019 in r/r B-cell ALL. Findings from JULIET are expected to be presented at an upcoming medical congress.

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2018-09-08T08:37:44+09:30April 18th, 2017|News|