ZYDELIG (idelalisib), kinase inhibitor
Reason for request
Date 17 June 2015
Moderate improvement, in combination with rituximab, in chronic lymphocytic leukaemia in second-line and subsequent therapy, and in the first line in case of deletion 17p or TP53 mutation.
Minor improvement in follicular lymphoma refractory to two prior lines of treatment.
- ZYDELIG has Marketing Authorisation in two indications:
- in combination with rituximab in the treatment of adults with chronic lymphocytic leukaemia (CLL) who have received at least one prior treatment or in the first line in case of deletion 17p or TP53 mutation, in patients for whom immunochemotherapy is not appropriate.
- in monotherapy in the treatment of adults with follicular lymphoma (FL) refractory to two prior lines of treatment.
- In treatment of CLL, in 2nd-line and subsequent therapy, ZYDELIG in combination with MABTHERA (rituximab) has shown an improvement in progression-free survival, in overall survival and in quality of life compared with rituximab alone.
- In 1st line treatment of patients with a deletion 17p (del17p) or TP53 mutation, efficacy data are very limited.
- In refractory FL, therapeutic benefit was observed in a non-comparative study based on the overall response rate. ZYDELIG as monotherapy is an alternative treatment in patients with FL refractory to two prior lines of treatment.
Improvement in actual benefit