From this June 30, 2022, FDA Drug Safety Communication, “FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)”, we get the following:
To evaluate the long-term safety of Copiktra, we required the drug manufacturer, Secura Bio, to submit the final 5-year survival results from the clinical trial, called DUO trial, a phase 3, randomized, open-label trial. It was conducted in 319 patients with CLL or SLL who received a previous therapy that did not work or stopped working. These final results showed a possible increased risk of death with Copiktra…. The serious side effects included infections, diarrhea, inflammation of the intestine and lungs, skin reactions, and elevated liver enzyme levels in the blood….
As background, Copiktra was approved by the FDA in 2018 to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior therapies that did not work or stopped working.
We will be watching for a future FDA Advisory Committee Meeting that will discuss the Copiktra clinical trial findings and, in turn, further assess the safety of Copiktra. Be assured we will report here about any significant developments, including whether Copiktra should continue to be prescribed for CLL and/or SLL cancer patients.[Read article in full at original source]
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