其 他 安 全 警 示
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| The United States: FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib) (English only) |
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The US Food and Drug Administration (FDA) announces that results from a clinical trial show a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a chronic blood cancer called leukemia and a lymphoma, a cancer found in the lymph nodes. The trial also found Copiktra 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.
FDA is notifying the public of these risks and is continuing to evaluate the safety of Copiktra. FDA plans to hold a future public meeting to discuss the findings from the clinical trial and whether Copiktra should continue to be prescribed for patients. FDA will update the public when it has more information.
Patients should talk to their health care professional about the risks and benefits of receiving Copiktra. Discuss any questions or concerns they may have, including about possible alternative treatments.
Health care professionals should consider the risks and benefits of continuing Copiktra in the context of other available treatments. Advise patients receiving Copiktra of the possible increased risk of death and higher risk of serious adverse events.
To evaluate the long-term safety of Copiktra, FDA 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 chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (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. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-possible-increased-risk-death-and-serious-side-effects-cancer-drug-copiktra
In Hong Kong, there is no registered pharmaceutical product containing duvelisib.
Ends/Monday, Jul 4, 2022
Issued at HKT 14:30
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