EU approves Zydelig for Follicular Lymphoma-Gilead Sciences

The European Commission has granted marketing authorization for Zydelig (idelalisib), 150 mg tablets, from Gilead Sciences, for Follicular Lymphoma (FL). For the treatment of FL, Zydelig has been approved as a monotherapy in patients who are refractory to two prior lines of treatment. The approval in FL, the most common type of indolent non-Hodgkin lymphoma (iNHL), is supported by data from a single-arm Phase II study (Study 101-09) of Zydelig monotherapy in 125 iNHL patients refractory to rituximab and alkylating-agent-containing chemotherapy. In the 72 patients with FL in this study, Zydelig achieved an overall response rate of 54 percent and the median duration of response was not reached (range: 0.0, 14.8+ months). Results of Study 116 and Study 101-09 were published in The New England Journal of Medicine in March 2014.