ZYDELIG (idelalisib), antineoplastic

High clinical benefit, in combination with rituximab, for the treatment of chronic lymphocytic leukaemia for patients who are not eligible for any other treatment but no proven clinical added value for the therapeutic strategy in respect of these patients

• ZYDELIG has been granted a marketing authorisation, in combination with rituximab, for the first-line treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation for patients who are not eligible for any other treatment.

• The efficacy of the idelalisib + rituximab combination is based on very limited data (n=9 patients) in exchange for high toxicity: risk of infections and neutropoenia.

• Pneumocystis jiroveci pneumonia prophylaxis and regular clinical and pathological cytomegalovirus infection and blood count monitoring are recommended.