IND filing Zydelig in combo with Arzerra

Gilead announces submission of a supplemental New Drug Application to use Zydelig® in combination with ofatumumab in previously treated patients with CLL
Submission based on data presented at American Society of Clinical Oncology Meeting 2015
Copenhagen, Denmark; June 1, 2015 — Genmab A/S (OMX: GEN) announced today that Gilead has published that it has submitted a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration to include data from a phase 3 study of Zydelig® (idelalisib) in combination with ofatumumab in previously-treated patients with chronic lymphocytic leukemia (CLL). As reported the study included 261 patients and the results showed a 73 percent reduction in the risk of disease progression or death for patients in the Zydelig plus ofatumumab arm versus the ofatumumab arm alone. The safety profile of Zydelig was similar to prior studies in previously-treated patients with CLL. Grade ≥3 adverse events occurring in the Zydelig plus ofatumumab arm included diarrhea/colitis (20.2 percent), pneumonia (12.7 percent) and febrile neutropenia (11.6 percent). The data was presented over the weekend at the American Society of Clinical Oncology Meeting 2015 held in Chicago, USA. Gilead also announced it plans to submit a supplemental filing to the European Medicines Agency later this year.