FDA Releases Drug Safety Communication regarding Cancer Drug, Copiktra

On June 30, the FDA released a drug safety communication that warned against the risks associated with Copiktra. Copiktra, also called duvelisib, is a cancer drug used to treat relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).  

The FDA first approved the drug in 2018 after a clinical trial found that it increased median progression-free survival by 7.3 months compared to ofatumumab, another cancer treatment drug.  

As stated in the announcement, “Copiktra works by blocking key signals that cause cancer cells to multiply, which may help reduce or stop the growth of certain types of cancer. Copiktra is in a class of medicines called PI3 kinase inhibitors and is available as a capsule that is swallowed.” 

In the original approval, the FDA stated that approximately 65% of patients taking duvelisib experienced side effects. However, the reaction occurrence could be mitigated by a dose reduction for 24% of patients.  

Regardless of the original approval, the drug safety communication identifies 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.” 

In addition to the risk of death, elevated liver enzymes, infections, skin reactions, diarrhea, and other side effects increased with duvelisib. 

The Copiktra website states that, of the 31% of patients who experienced infection, including pneumonia, sepsis, and lower respiratory infections, 4% of infections were fatal. Diarrhea or colitis was experienced in 18% of patients, and cutaneous reactions and pneumonitis each occurred in 5% of patients. Hepatotoxicity and neutropenia also occurred.  

Of the 442 patients who received Copiktra, 36 had fatal adverse reactions within 30 days of the last dose.  

Currently, the FDA is working to disseminate information on the potential risks associated with taking Copiktra to patients and healthcare providers. While the FDA intends to “hold a future public meeting to discuss the findings from the clinical trial and whether Copiktra should continue to be prescribed for patients,” as stated in the drug safety communication, they advise that patients weigh the benefits of Copiktra with its potential side effects.  

The FDA encourages physicians and other patient care team members to keep patients apprised of the drug’s side effects and consider medication history, genetics, and comorbidities when assessing Copiktra risk.