EU approves Zydelig for CLL-Gilead Sciences

The European Commission has granted marketing authorization for Zydelig (idelalisib), 150 mg tablets, from Gilead Sciences, for Chronic Lymphocytic Leukemia (CLL). For the treatment of CLL, Zydelig has been approved for use in combination with rituximab for patients who have received at least one prior therapy; or as first-line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.

The approval of Zydelig is supported primarily by data from a randomized, placebo-controlled Phase III trial (Study 116) of Zydelig plus rituximab in 220 patients with relapsed CLL who were not able to tolerate standard chemotherapy. Study 116 was stopped early in October 2013 by an independent Data Monitoring Committee due to a highly statistically significant benefit in progression-free survival (PFS) in the Zydelig plus rituximab arm compared with the rituximab only treatment arm. Median PFS was not reached in the Zydelig plus rituximab arm (10.7 months) and was 5.5 months in the placebo plus rituximab arm.