Kymriah® is indicated for the treatment of paediatric and young adult patients up to and including 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse, and adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.1
View the safety profile of Kymriah from the JULIET clinical trial (Go to Kymriah efficacy for study information). For further information, please refer to the Summary of Product Characteristics for full safety information.
Summary of the safety profile1
|DLBCL 115 patients infused with Kymriah in a global, multicentre, international study; JULIET (CCTL019C2201)|
|All Grades||Grade 3/4|
|Most common non-haematological adverse reactions|
|Cytokine release syndrome||57%||23%|
|Most common haematological adverse reactions|
|Decreased white blood cells||99%||78%|
Description of selected adverse drug reactions1
|DLBCL 115 patients infused with Kymriah in a global, multicentre, international study; JULIET(CCTL019C2201)|
|All Grades||Grade 3/4||Grade 3 or higher|
|Cytokine Release Syndrome‡||57%||23%|
|Neurological adverse reactions§ – encephalopathy and/or delirium||20%||11%|
*All adult DLBCL patients had Grade 3 and 4 cytopenias at some time after Kymriah infusion.
†Not resolved by Day 28.
‡CRS was graded according to the PENN scale.
§Majority of neurological events occurred within 8 weeks following infusion and were transient.
¶37% of DLBCL patients experienced an infection of any type within 8 weeks.
CRS, cytokine release syndrome; DLBCL, diffuse large B-cell lymphoma; PENN scale, University of Pennsylvania grading scale; WBC, white blood cell.
- Kymriah Summary of Product Characteristics; Novartis Pharmaceuticals UK Ltd.