Kymriah - EC - SmPC new text

On 26 April 2023 the Commission Decision has been issued with updated Kymriah SmPC text as follows:

Update of section 4.2 of the SmPC in order to update the paediatric statement for the B-cell ALL indication and section 4.4 to update the warning on ‘prior treatment with anti-CD19 therapy’ as well as sections 4.4 and 4.8 in order to update safety data to reflect the pool of the 3 studies B2202, B2205J and B2001X.

Update of section 5.1 of the SmPC based on a subgroup analysis from CCTL019B2401 (B2401) disease registry listed as a PAES (ANX006) in the Annex II; this is a non-interventional study to evaluate the efficacy and safety of Kymriah in ALL patients below the age of 3 years.

link to SmPC in Italian