News Brief: FDA Warns of Serious Adverse Effects, Possible Increased Risk of Death With Cancer Drug Duvelisib

On June 30, 2022, the Food and Drug Administration (FDA) warned that findings from a recent clinical trial revealed a possible increased risk of death with the oral cancer drug duvelisib (COPIKTRA) compared with another cancer medication in patients who have a type of blood cancer called chronic lymphocytic leukemia or a type of cancer of the lymph nodes known as small lymphocytic lymphoma.[1]

Duvelisib was approved by the FDA in 2018 for treating certain patients who had either chronic lymphocytic leukemia or small lymphocytic lymphoma.[2] The FDA required that the maker of the drug conduct additional studies to further assess its risks and benefits. One post-approval study provided long-term survival data from a clinical trial that enrolled 319 patients who had either chronic lymphocytic leukemia or small lymphocytic lymphoma and been randomly assigned to receive either duvelisib or the injected cancer drug ofatumumab (ARZERRA, KESIMPTA). The FDA reported that after a median follow-up of 63 months, there was an estimated 9% higher risk of death in the patients treated with duvelisib, although the difference was not statistically significant. In addition, the rates of serious adverse events — including infections, diarrhea, inflammation of the intestines and lungs, skin reactions and abnormal blood tests indicative of potential liver damage — and death due to these adverse effects were also higher in patients who received duvelisib.[3]

The FDA advised patients being treated with duvelisib to talk to their doctors about the risk and benefits of continuing the drug and about possible alternative treatments.[4] The agency also plans to convene a public advisory committee meeting to consider whether duvelisib should continue to be prescribed to patients.[5]
 

References

[1] Food and Drug Administration. FDA drug safety communication: FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib). June 30, 2022. https://www.fda.gov/media/159559/download. Accessed August 10, 2022.

[2] Securo Bio, Inc. Label: duvelisib (COPIKTRA). December 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211155s005lbl.pdf. Accessed August 10, 2022.

[3] Food and Drug Administration. Letter to Verastem Inc., NDA 21115/Original 1, accelerate approval. September 24, 2018. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211155Orig1s000ltr.pdf. Accessed August 10, 2022.

[4] Ibid.

[5] Ibid.