ISSUE: The FDA is
warning 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.
The FDA is notifying the public of these risks and is continuing to
evaluate the safety of Copiktra. The 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. The FDA will
update the public when more information is available.
For more
information about this alert, click on the red button "Read Alert" below.
BACKGROUND: Copiktra
was approved to treat adults with chronic lymphocytic leukemia or small
lymphocytic lymphoma who have received at least two prior therapies
that did not work or stopped working.
RECOMMENDATIONS:
- Patients
Patients should talk to your health care professional about the
risks and benefits of receiving Copiktra for you. Discuss any
questions or concerns you may have, including about possible
alternative treatments.
- Health
Professionals
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.
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