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

On 17^th January 2018, Novartis announced in a press release that 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 Application that 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^TM in this indication. Stephen Schuster, Director of Lymphoma at Penn Medicine, presented the primary analysis of the JULIET trial at the American Society of Hematology 2017, that demonstrated a complete response rate of 30% that was sustained up to 6 months in 95% of patients. Dr Schuster was interviewed by 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^TM was 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 EMA in 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).