Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. On June 30, 2022, FDA warned that results from a clinical trial show a possible increased risk of death with Copiktra (active ingredient duvelisib) compared to another medicine to treat leukemia and lymphoma. The trial 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.
We are notifying the public of these risks and are continuing to evaluate the safety of Copiktra. We plan to hold a future public meeting to discuss the findings from the clinical trial and whether Copiktra should continue to be prescribed for patients. We will update the public when we have more information.
Copiktra was approved in 2018 to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior therapies that did not work or stopped working. With the approval in 2018, the information on survival or risk of death was limited, and the FDA required longer follow-up from the clinical trial to gain more information.
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.
To evaluate the long-term safety of Copiktra, we required the drug manufacturer, Secura Bio, to submit the final 5-year survival results from the clinical trial, called DUO trial, a phase 3, randomized, open-label trial. It was conducted in 319 patients with CLL or SLL who received a previous therapy that did not work or stopped working. These final results showed a possible increased risk of death with Copiktra compared to the monoclonal antibody ofatumumab. The rate of serious side effects, dose modifications, and deaths resulting from these side effects were also higher among patients who received Copiktra. The serious side effects included infections, diarrhea, inflammation of the intestine and lungs, skin reactions, and elevated liver enzyme levels in the blood. These safety findings were similar for other medicines in the same PI3 kinase inhibitor class, which were discussed at an advisory committee meeting of non-FDA experts in April of 2022.
All medicines have risks even when used correctly as prescribed. It is important to know that people respond differently to all medicines depending on their health, other medicines they are taking, the diseases they have, genetic factors, and many other reasons. As a result, we cannot determine how likely it is that someone will experience these risks when taking Copiktra.
Side effects involving Copiktra and other medicines should be reported to FDA’s MedWatch reporting program at www.fda.gov/medwatch.
A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at email@example.com. And follow us on Twitter @FDA_Drug_Info.
- FDA Drug Safety Communication: FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)