FDA Updates Evusheld Dosing Recommendations
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July 6, 2022June 30, 2022 – 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.