Gilead Sciences To Stop Phase III Study Of Idelalisib - Quick Facts

(RTTNews) - Gilead Sciences, Inc. (GILD) Wednesday said it will stop the Phase III study of idelalisib for the treatment of chronic lymphocytic leukemia, following recommendation by an independent Data Monitoring Committee.

"Given the significant unmet medical need in CLL, particularly in this population of patients who are not fit for chemotherapy, we are pleased that idelalisib has shown a clinically meaningful benefit for patients," said Norbert Bischofberger, Gilead's EVP, R&D and Chief Scientific Officer.

The independent Data Monitoring Committee said that idelalisib shows highly statistically significant efficacy for the primary endpoint of progression-free survival in patients.

The safety profile of idelalisib was acceptable and consistent with prior experience in combination with rituximab in previously treated disease.

A new drug application for idelalisib was earlier submitted for refractory indolent non-Hodgkin's lymphoma on September 11. Gilead is now seeking regulatory approval of idelalisib in the European Union later this year.