Zydelig is indicated in combination with an anti‑CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL)...as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.

Suggested treatment regimens...CLL/SLL with del(17p)/TP53 mutation…Relapsed/refractory therapy…preferred regimen…idelalisib + rituximab

Recommendations: TP53 mutation or del(17p): ibrutinib or acalabrutinib or venetoclax plus obinutuzumab or venetoclax alone or idelalisib plus rituximab [III, A].

...- Previously untreated CLL requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008)] with deletion 17p13 and/or TP53 mutation....

Thirty-seven patients with relapsed/refractory disease were included. The median number of prior lines of therapy was 3 (range 1-11); the median age was 69 years (range 50-89); 22% had Cumulative Illness Rating Scale (CIRS) >6 and 51% had del(17p)/TP53 mutation. The overall response rate was 65% (all but one was partial response [PR]). The median duration of therapy was 9.8 months (range 0.9-44.8). The median progression-free survival was 16.4 months (95% CI: 10.4-26.3)...Our real-world results suggest that idelalisib is an effective and relatively safe treatment for patients with advanced-stage CLL when no other therapies exist.

Randomisation was stratified by high-risk features (IGHV, del[17p], or TP53 mutation)... Idelalisib in combination with bendamustine plus rituximab improved progression-free survival compared with bendamustine plus rituximab alone in patients with relapsed or refractory chronic lymphocytic leukaemia.