FDA Warns of Serious Risks From Leukemia/Lymphoma Drug

The FDA issued a warning regarding duvelisib and a potentially increased risk of death and serious side effects for patients taking the medication.

Duvelisib was approved in 2018 to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose disease was refractory to at least two other therapies. At that time, the information on survival or risk of death was limited, and the FDA required a longer follow-up from the clinical trial to gain that information.

Now, results from a clinical trial (NCT02004522) suggest possible increased risk of death with duvelisib compared to another medicine (ofatumumab) in patients with CLL or SLL. The trial also found that duvelisib 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.

The FDA is continuing to evaluate duvelisib’s safety and will update health care professionals and the public when more information is available.

Duvelisib, which is available as a capsule, works by blocking key signals that cause cancer cells to multiply, which may help reduce or stop the growth of certain types of cancer.

More specifically, the drug is an orally bioavailable, highly selective and potent small molecule inhibitor of the delta and gamma isoforms of phosphoinositide-3 kinase (PI3K) with potential immunomodulating and antineoplastic activities, according to the National Library of Medicine, citing the National Cancer Institute.

Patients are advised to talk to their health care professionals about the risks and benefits of receiving duvelisib. Health care professionals are advised to consider the risks and benefits of continuing duvelisib in the context of other available treatments and to discuss this with patients receiving duvelisib.

Both groups are encouraged to report adverse events or side effects related to the use of duvelisib to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Duvelisib is marketed by SecuraBio as Copiktra.