The U.S. FDA has issued a safety warning for Secura Bio’s Copiktra® (duvelisib), a treatment for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

• Data from a recent clinical trial shows a possible increased risk of death and serious side effects with Copiktra compared to another medicine used to treat leukemia and lymphoma.
• The FDA advises patients and their healthcare providers to discuss the risks and benefits of Copiktra in the context of other possible treatment alternatives.
• First FDA approved in 2018, Copiktra is indicated to treat adults who have relapsed or refractory CLL and SLL after at least two prior therapies.