EMA reviewing Gilead's Zydelig due to SAE concerns

EMA started a review of Zydelig idelalisib from Gilead Sciences Inc. (NASDAQ:GILD) due to concerns about increased rates of serious adverse events, including deaths, in three clinical trials evaluating combinations that included the blood cancer drug. EMA said the SAEs were "mostly due to infections," and occurred in patients with chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin's lymphoma (NHL).

Zydelig is approved in the EU in combination with rituximab to treat second-line CLL and treatment-naive CLL patients with certain mutations, and as monotherapy to treat follicular lymphoma (FL), a form of NHL. ...