FDA Copiktra Warning About Higher Risk of Death

FDA is warning about a possible increased risk of death with the Secura Bio cancer drug Copiktra (duvelisib) compared to another medicine to treat leukemia and lymphoma. A Drug Safety Communication says the risk was seen in results from a clinical trial that also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood.

FDA says it is continuing to evaluate Copiktra's safety and will hold a public meeting in the future to discuss the trial findings and whether the drug should continue to be prescribed for patients.

Copiktra was first approved in 2018 to treat adults with chronic lymphocytic leukemia or small lymphocytic leukemia who have received at least two prior therapies that did not work or stopped working.