The United States Food and Drug Administration has issued an FDA Drug Safety Announcement that cautions about the potentially heightened risk of death and severe side effects with cancer medication Copiktra (duvelisib).
What Safety Issue is the FDA Disclosing About Copiktra?
The U.S. Food and Drug Administration (FDA) is cautioning that a clinical trial indicates a potentially elevated risk of death with Copiktra (duvelisib) compared to another drug for treating chronic leukemia, a blood cancer, and lymphoma, cancer found in the lymph nodes. The trial also discovered that Copiktra had a higher risk of severe side effects, such as infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and elevated liver enzyme levels in the blood.
What Actions is the FDA taking?
We are informing the public about these risks and continuing to assess Copiktra’s safety. We intend to convene a future public meeting to discuss the clinical trial’s findings and whether Copiktra should still be prescribed for patients. We will provide updates to the public when more information becomes available.
What is Copiktra?
Approved in 2018, Copiktra is a treatment for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have tried at least two previous therapies that were ineffective or stopped working. CLL is cancer originating in white blood cells, while SLL mostly starts in the lymph nodes. The 2018 approval came with limited information on survival or risk of death, and the FDA required extended follow-up from the clinical trial for more information. Copiktra functions by blocking essential signals that cause cancer cells to multiply, potentially reducing or stopping the growth of certain cancer types. Copiktra belongs to a class of drugs called PI3 kinase inhibitors and is administered as an oral capsule.
What did the FDA discover?
The FDA required drug manufacturer Secura Bio to submit the final 5-year survival results from the DUO trial, a phase 3, randomized, open-label trial conducted with 319 CLL or SLL patients who had received previous therapy that was unsuccessful or ceased working. These final results revealed a potential increased risk of death with Copiktra compared to the monoclonal antibody ofatumumab (see Data Summary below for more information). The incidence of serious side effects, dose adjustments, and deaths resulting from these side effects was also higher among Copiktra patients. The serious side effects included infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and raised liver enzyme levels in the blood (see Data Summary below for more information). These safety findings were similar for other drugs in the same PI3 kinase inhibitor class, discussed at an advisory committee meeting of non-FDA experts in April 2022.
What should patients do?
Patients should discuss the risks and benefits of using Copiktra with their healthcare professionals. Address any questions or concerns, including possible alternative treatments.
What should healthcare professionals do? Healthcare professionals should weigh the risks and benefits of continuing Copiktra in relation to other available treatments. Inform patients taking Copiktra of the potential increased risk of death and heightened risk of serious adverse events.
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Did you lose a loved one while they were undergoing treatment with the cancer drug Copiktra (duvelisib) for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)? Recent findings from a clinical trial have raised concerns about the potential increased risk of death and serious side effects associated with Copiktra. It’s time to take action and protect your rights.
At Parker Waichman LLP, our national product liability lawsuit law firm understands the gravity of this situation and the impact it may have on patients and their families. Our experienced legal team is dedicated to advocating for the rights of individuals who have been affected by dangerous drugs.
If you or someone you know taking Copiktra has experienced adverse side effects or fatal complications, we urge you to call us immediately at our toll-free number: 1-800-YOUR-LAWYER (1-800-968-7529). Our compassionate and knowledgeable Copiktra Wrongful Death Attorneys are ready to listen to your concerns, answer your questions, and guide you through the legal process and work hard to obtain financial compensation.
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