Future FDA Advisory Committee Meeting Will Discuss Whether Copiktra Should be Used as CLL or SLL Treatment
(Posted by Tom Lamb at Drug Injury Watch)
As background, Copiktra (duvelisib) 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. However, because the information on survival or risk of death was limited in 2018, simultaneous with approving Copiktra the FDA required a longer follow-up from an underlying Copiktra clinical trial to gain more information about the safety of Copiktra.
So where do things stand now as regards the safety of Copiktra?
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 compared to the monoclonal antibody ofatumumab (see Data Summary below for additional information). The rate of serious side effects, dose modifications, and deaths resulting from these side effects were also higher among patients who received Copiktra. The serious side effects included infections, diarrhea, inflammation of the intestine and lungs, skin reactions, and elevated liver enzyme levels in the blood (see Data Summary below for additional information). These safety findings were similar for other medicines in the same PI3 kinase inhibitor class, which were discussed at an advisory committee meeting of non-FDA experts in April 2022.
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As mentioned therein, Copiktra is in the PI3 kinase inhibitors class of drugs, and it works by blocking key signals that cause cancer cells to multiply, which may help reduce or stop the growth of certain types of cancer, such as the CLL type of leukemia and the SLL type of lymphoma.
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.
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