FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)
Consider risks and benefits of continued use versus other treatments
Drug Safety Communication (PDF - 282 KB)
6-30-2022 FDA Drug Safety Communication
The U.S. Food and Drug Administration (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.
We are notifying the public of these risks and are continuing to evaluate the safety of Copiktra. We plan to hold a future public meeting to discuss the findings from the clinical trial and whether Copiktra should continue to be prescribed for patients. We will update the public when we have more information.
Copiktra was approved 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. CLL is a type of cancer that begins in the white blood cells, and SLL is a type of cancer that begins mostly in the lymph nodes. With the approval in 2018, the information on survival or risk of death was limited, and the FDA required longer follow-up from the clinical trial to gain more information.
Copiktra works by blocking key signals that cause cancer cells to multiply, which may help reduce or stop the growth of certain types of cancer. Copiktra is in a class of medicines called PI3 kinase inhibitors and available as a capsule that is swallowed.
Patients should talk to your health care professional about the risks and benefits of receiving Copiktra. Discuss any questions or concerns you 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, 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.
All medicines have risks even when used correctly as prescribed. It is important to know that people respond differently to all medicines depending on their health, other medicines they are taking, the diseases they have, genetic factors, and many other reasons. As a result, we cannot determine how likely it is that someone will experience these risks when taking Copiktra.
To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving Copiktra or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.
You can sign up for email alerts about Drug Safety Communications on medicines or medical specialties of specific interest to you.
- Copiktra is approved to treat adults with chronic lymphocytic leukemia (CLL), a type of blood cancer found in the blood and bone marrow, and small lymphocytic lymphoma (SLL), a type of cancer found in the lymph nodes, who have received at least two prior therapies that did not work or stopped working.
- Copiktra is in a class of medicines called PI3 kinase inhibitors. 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.
- Copiktra is available as a capsule taken by mouth twice daily.
- Common side effects of Copiktra include tiredness, fever, cough, nausea, upper respiratory infection, bone and muscle pain, and low red blood cell count.
- FDA is warning that results from a clinical trial showed a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a blood cancer called chronic lymphocytic leukemia (CLL) and a cancer found in the lymph nodes called small lymphocytic lymphoma (SLL).
- The clinical trial also found a higher risk of serious side effects with Copiktra that include infections, diarrhea, inflammation of the intestine and lungs, skin reactions, and high liver enzyme levels in the blood.
- Talk to your doctor about the risks and benefits of continuing to receive Copiktra or about possible alternative treatments.
- Read the patient Medication Guide every time you receive a prescription for Copiktra as the information may be updated. The Medication Guide explains the important things you need to know about the medicine. These include the side effects, what the medicine is used for, how to take and store it properly, and other things to watch out for when you are taking the medicine.
- To help FDA track safety issues with medicines, report side effects from Copiktra or other medicines to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of this page.
- You can sign up for email alerts about Drug Safety Communications on medicines or medical specialties of specific interest to you.
- FDA is warning that results from a clinical trial showed a possible increased risk of death with Copiktra (duvelisib) compared to the monoclonal antibody ofatumumab to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- The clinical trial found Copiktra was associated with a higher risk of serious side effects that include infections, diarrhea, inflammation of the intestine and/or lungs, skin reactions, and elevated liver enzymes.
- Review patients’ progress on Copiktra and discuss the risks and benefits of continuing Copiktra in the context of other available treatments.
- Encourage patients to read the Medication Guide they receive with each prescription, which explains the safety risks and provides other important information, as the information may be updated.
- To help FDA track safety issues with medicines, report adverse events involving Copiktra (duvelisib) or other medicines to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of this page.
- You can sign up for email alerts about Drug Safety Communications on medicines or medical specialties of specific interest to you.
Copiktra was approved in 2018 based on the benefit-risk evaluation of data available at the time from the DUO trial for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy. The DUO trial was a phase 3, randomized, open-label trial that evaluated Copiktra versus the monoclonal antibody ofatumumab in 319 patients with relapsed or refractory CLL or SLL who received at least one prior line of therapy. The primary endpoint was progression-free survival. At the time of initial approval, the overall survival information was limited, and FDA required the drug manufacturer, Secura Bio, to submit the final analysis of overall survival at 5 years in the trial to enable us to evaluate Copiktra’s long-term safety.
With a median of 63 months follow-up, the final overall survival results showed a possible increased risk of death with Copiktra, with a hazard ratio of 1.09 (95% confidence interval [CI] 0.79, 1.51) (see Table 1 below). Among the subpopulation of patients receiving at least two prior lines of therapy – the FDA approved use – the hazard ratio was 1.06 (95% CI 0.71, 1.58). In addition to the risk of death, the incidence of deaths due to adverse events, serious adverse events, Grade ≥3 adverse events, and treatment modifications due to adverse events were higher among patients receiving Copiktra.
Table 1. Summary of Final Overall Survival (OS) Data in the DUO Trial, ITT population
|
|
Copiktra (N=160) |
Ofatumumab (N=159) |
|---|---|---|
|
Deaths, n (%) |
80 (50) |
70 (44) |
|
Median OS, months (95% CI) |
52.3 (41.8, 68) |
63.3 (41.2, NE) |
|
HR for OS (95% CI) |
1.09 (0.79, 1.51) |
|
NE=not estimable; HR=hazard ratio; CI=confidence interval.
Related Information
National Cancer Institute: Leukemia
National Cancer Institute: Lymphoma
The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective
Think It Through: Managing the Benefits and Risks of Medicines
Advisory Committees: Critical to the FDA's Product Review Process
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