FDA Highlights Risks of Secura Bio’s Copiktra

The FDA issued an updated warning about an increased risk of death for leukemia and lymphoma patients treated with Secura Bio’s cancer drug Copiktra (duvelisib).

The agency had previously issued a public safety notice last June, but has updated it based on new data showing that the treatment led to a 9 percent increased risk of death compared to standard treatment in patients with leukemia and lymphoma.

The drug is also 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 agency said.

Copiktra, which works by blocking an enzyme that can cause cancer cells to multiply, was approved in 2018 for treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia who have received at least two prior therapies that did not work or stopped working.

The FDA’s Oncologic Drugs Advisory Committee will discuss the matter in a Sept. 23 meeting.