The approval in CLL is supported primarily by data from a randomized, placebo-controlled phase 3 trial in combination with rituximab in 220 patients with relapsed CLL who were not able to tolerate standard chemotherapy. The approval in FL, is supported by data from a single-arm phase 2 study (Study 101-09) of Zydelig monotherapy in 125 iNHL patients refractory to rituximab and alkylating-agent-containing chemotherapy.
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the European Commission has granted marketing authorization for Zydelig® (idelalisib), 150 mg tablets, a first-in-class oral treatment for two incurable blood cancers - chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). 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. For the treatment of FL, Zydelig has been approved as a monotherapy in patients who are refractory to two prior lines of treatment. Zydelig inhibits PI3K delta, a protein that is overexpressed in many B-cell malignancies and plays a role in the viability, proliferation and migration of these cancer cells.
Press release from Gilead: http://bit.ly/1r5ONwo