Cancer Drug Copiktra Linked To Increased Risk of Death, FDA Warns

Side effects of Copiktra may increase the risk of death and other serious injuries for cancer patients, raising questions about the future of the medication

Federal drug regulators are warning that side effects of Copiktra, a drug used to treat certain blood cancers, may actually increase the risk of death and other serious injuries.

In a drug safety communication issued on June 30, the U.S. Food and Drug Administration (FDA) notified patients, oncologists and other medical providers that data from a recent clinical trial found an increased risk of death on Copktra compared to other cancer treatments, and the drug was also associated with a higher risk of infections, diarrhea, inflammation, skin reactions and elevated liver enzyme levels.

Copiktra (duvelisib) was first approved in 2018, for treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who received at least two prior therapies that did not work or stopped working. It is now used to treat leukemia, a chronic blood cancer, and lymphoma, a cancer found in the lymph nodes. Copiktra belongs to a class of drugs known as PI3 kinase inhibitors, which block important chemical signals which cause cancer cells to multiply.

The FDA warning comes after a review of data from a study that evaluated five-year survival results from the randomized phase 3 DUO clinical trial. Survival rates were 13 months less, on average, compared to other leukemia and lymphoma drugs. The clinical trial also indicated Copiktra was linked with a higher risk of serious and potentially life-threatening side effects among cancer patients.

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In April, the FDA withdrew approval of the indication for Copiktra for relapsed or refractory follicular lymphoma following a voluntary request by the manufacturer Secura Bio Inc. Similarly, the FDA withdrew approval for Ukoniq, another PI3 kinase inhibitor, in early June following an investigation into a possible increased risk of death.

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 the meantime, the agency recommends patients taking the medication talk to their doctor about the risks and benefits of receiving Copiktra, as well as discussing concerns and possible alternative treatments.

In its recommendations to the medical community, the FDA indicated healthcare professionals should consider the risks and benefits of continuing Copiktra in the context of other available treatments that may be more effective with less risk. They should advise patients receiving Copiktra of the possible increased risk of death and higher risk of serious adverse events.

Patients and healthcare professionals are encouraged to report adverse events or side effects related to the use of Copiktra to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.


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