FDA approves Zydelig for CLL, NHL and SLL - Gilead Sciences

The FDA has approved Zydelig (idelalisib), from Gilead Sciences, for the treatment of three B-cell blood cancers: as 150mg tabs, it is indicated in combination with rituximab for patients with relapsed Chronic Lymphocytic Leukemia (CLL) for whom rituximab alone would be considered appropriate therapy and as monotherapy for patients with relapsed follicular B-cell Non-Hodgkin Lymphoma (FL) and Small Lymphocytic Lymphoma (SLL) who have received at least two prior systemic therapies. Accelerated approval was granted for FL and SLL based on overall response rate.

Approval in CLL 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 arm as compared to those receiving rituximab alone. Median PFS was not reached in the Zydelig plus rituximab arm and was 5.5 months in the placebo plus rituximab arm.