The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Gilead Sciences’ marketing authorisation application for Zydelig to treat chronic lymphocytic leukaemia (CLL) and follicular lymphoma (FL).
Zydelig has been recommended for use in combination with rituximab to treat adult patients with CLL who have received at least one prior therapy or, as first-line treatment in CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
It is also recommended as monotherapy for treatment of adult patients with FL that is refractory to two prior lines of treatment.
“In the Phase II 101-09 study, Zydelig’s safety and efficacy has been evaluated in patients with indolent non-Hodgkin’s lymphoma who are refractory to rituximab and alkylating agents.”
The European Commission will now review the CHMP’s recommendation for Zydelig. Its recommendation for approval in the EU is supported by positive data from the Phase III (Study 116) trial and the Phase II (Study 101-09) trial.
The Phase III Study 116 has evaluated the safety and efficacy of Zydelig in combination with rituximab in patients with previously treated CLL.
In the Phase II 101-09 study, Zydelig’s safety and efficacy has been evaluated in patients with indolent non-Hodgkin’s lymphoma who are refractory to rituximab and alkylating agents.
Diarrhoea, pyrexia, fatigue, nausea, cough, abdominal pain and chills were the most commonly reported adverse reactions in these studies.
Gilead Sciences recently received approval from the US Food and Drug Administration (FDA) for Zydelig (idelalisib) 150mg tablets for the treatment of CLL, FL, and small lymphocytic lymphoma. Zydelig is an oral inhibitor of phosphoinositide 3-kinase delta.