Blood Cancer Drug, Copiktra, May Increase Risk of Death, Severe Side Effects, FDA Warns

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Long-term clinical trial data showed that the use of Copiktra was associated with an increased rate of death and severe side effects for patients with chronic lymphocytic leukemia and small cell leukemia.

The Food and Drug Administration (FDA) recently published a warning regarding Copiktra (duvelisib), a PI3K inhibitor used to treat patients with chronic lymphocytic leukemia (CLL) and small cell leukemia (SLL), as clinical trial results showed that the drug may increase risk of death or serious side effects compared to other therapies for the two blood cancers.

“Patients should talk to your health care professional about the risk and benefits of receiving Copiktra,” the FDA said in a statement. “Discuss any questions or concerns you may have, including about possible alternative treatments.”

Copiktra was approved for CLL and SLL, along with relapsed/refractory follicular lymphoma treatment in September 2018, though at that time, information of survival and risk of death was limited, according to the FDA. Then, in December 2021, Secura Bio, the manufacturer of the drug, voluntarily pulled Copiktra off the market for its follicular lymphoma indication.

Regarding long-term safety of the drug in CLL and SLL, the FDA requested five-year results from the phase 3 DUO trial, which involved 319 patients with CLL or SLL whose disease stopped responding to prior treatment. Findings showed a possible increased risk of death with Copiktra compared to treatment with Kesimpta (ofatumumab).

Long-term data from DUO also showed that Copiktra led to a higher rate of serious side effects, such as infections, diarrhea, intestinal or lung inflammation, skin reactions and elevated liver enzymes in the blood.

Read more: Better Data Needed to Approve Future PI3K Inhibitors for Blood Cancers, FDA Panel Recommends

The FDA urged patients to report any Copiktra-related side effects to their health care provider, and to the agency. However, it is difficult to determine which patients will develop side effects, and how severe they may be.

“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,” the FDA said.


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