Copiktra (duvelisib) linked to Possible Increased Risk of Death and Serious Side Effects

The FDA warns that results from a clinical study show an increased risk of death with a drug called Copiktra (duvalumab) compared to another drug to treat a type of blood cancer called acute myeloid leukemia (AML). The trial also showed that Copiktra was associated with a higher risk of serious adverse events, including infections, diarrhea, and inflammation of the intestines, lungs, and skin.

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.

BACKGROUND: 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. 

RECOMMENDATIONS: 

• Patients should talk to their health care professional about the risks and benefits of receiving Copiktra for them. Discuss any questions or concerns you may have, including possible alternative treatments. 

Health care professionals should consider the risks and benefits of continuing Copiktra in the context of other available treatments. Advise patients receiving Copiktra of the possible increased risk of death and higher risk of serious adverse events.