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FDA priority review for KymriahTM (tisagenlecleucel) in the treatment of adult R/R DLBCL

Jan 17, 2018

On 17 thJanuary 2018, Novartis announced in a press releasethat their CAR-T therapy Kymriah TM(tisagencleucel) has been granted Priority Review by the US Food and Drug Administration (FDA)for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell Lymphoma (DLBCL) and who are ineligible for autologous stem cell transplant or have relapsed after transplant. This follows a Biologics License Applicationthat was submitted to the FDA in November 2017.

Data from the JULIET study in adult R/R DLBCL helped to support the application for Kymriah TMin this indication. Stephen Schuster, Director of Lymphoma at Penn Medicine, presented the primary analysisof the JULIET trial at the American Society of Hematology2017, that demonstrated a complete response rate of 30% that was sustained up to 6 months in 95% of patients. Dr Schuster was interviewedby the Lymphoma Hub at the International Conference on Malignant Lymphoma ( ICML) 2017 on the interim analysis of the JULIET trial. He described CAR-T therapy as a "transformation in the field of lymphoma therapeutics" and that it could "save many more lives than we have been able to in the past."

Kymriah TMwas the first CAR-T therapy approved in the US for the treatment of young patients up to the age of 25 diagnosed with R/R B-cell precursor acute lymphoblastic leukemia (ALL). A marketing authorization application was also submitted to the EMAin November 2017 for two indications; the treatment of children and young adults with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (ALL) and adult patients with R/R diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT).