FDA issues safety warning on Secura Bio's Copiktra

The US Food and Drug Administration (FDA) yesterday issued a warning that results from a clinical trial show a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a chronic blood cancer called leukemia and a lymphoma, a cancer found in the lymph nodes.

The trial also found P13K inhibitor Copiktra, which is under development at US biotech firm Secura Bio, 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.

The FDA is notifying the public of these risks and is continuing to evaluate the safety of Copiktra. The FDA plans to hold a future public meeting to discuss the findings from the clinical trial and whether Copiktra should continue to be prescribed for patients. The FDA will update the public when more information is available.

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