The Food and Drug Administration (FDA) in the United States is warning that data from a clinical trial reveal a probable higher risk of mortality with Copiktra (duvelisib) as compared to another drug used to treat leukemia, chronic blood cancer, and lymphoma, a disease of the lymph nodes. Copiktra was also linked to an increased incidence of significant side effects such as infections, diarrhea, intestinal and lung inflammation, skin responses, and elevated blood liver enzyme levels.

About the cancer medicine COPIKTRA:

COPIKTRA® is a prescribed cancer medicine, which was approved in 2018 to treat individuals with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have failed or are no longer responding to at least two prior therapies. It is unknown if COPIKTRA is safe and effective in children under the age of 18. It is an oral phosphoinositide 3-kinase (PI3K) inhibitor and the first FDA-approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to assist the proliferation and survival of malignant cells. Copiktra’s major constituent, duvelisib, inhibits the actions of two enzymes (PI3K-delta and PI3K-gamma) that are hyperactive in blood malignancies. These enzymes allow cancer cells to grow and survive. Duvelisib causes cancer cells to die by inhibiting the actions of the enzymes, so slowing or preventing the progression of the disease.

Copiktra belongs to a family of drugs known as PI3 kinase inhibitors. It works by inhibiting crucial signals that drive cancer cells to divide, potentially slowing or stopping the growth of some forms of cancer. Copiktra is available as a capsule that is taken twice a day by mouth.

Side effects of this cancer medicine:

Copiktra often causes fatigue, fever, cough, nausea, upper respiratory infection, bone and muscular discomfort, and low red blood cell count. With the 2018 clearance, the FDA needed to prove this cancer medicine impact factor and a longer follow-up from the clinical study to collect additional information on survival or risk of death.

Diarrhea or colitis (inflammation of the large bowel), neutropenia (low levels of neutrophils, a type of white blood cell), rash, exhaustion, fever, cough, nausea (feeling sick), upper respiratory tract infection (infection of the nose and throat), pneumonia (infection of the lungs), musculoskeletal pain (pain in the muscle and bones), and anemia (low red blood cell count) are the most frequent side effects with Copiktra. Pneumonia, colitis, and diarrhea are the most typical major side effects.

FDA’s Findings:

The information on survival or danger of death was approved in 2018. To assess Copiktra’s long-term safety, FDA needed the medication manufacturer, Secura Bio, to submit the final 5-year survival findings from the DUO study, a phase 3, randomized, open-label trial. It involved 319 individuals with CLL or SLL who had previously failed or ceased responding to medication. These final findings indicated that Copiktra, cancer medicine pills may be associated with an increased risk of mortality when compared to the monoclonal antibody ofatumumab. Patients who received Copiktra had a greater risk of major long-term side effects of cancer treatment, dosage adjustments, and fatalities as a result of these side effects. The FDA has notified the public of these hazards and is continuing to assess Copiktra’s safety. They want to organize a future public conference to examine the clinical study outcomes and if Copiktra should be administered to patients in the future.

FDA guidelines for patients:
  • The FDA is warning that data from a clinical trial revealed a probable higher risk of death with Copiktra (duvelisib) compared to another drug used to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) (SLL).
  • The clinical investigation also discovered a greater chance of major adverse effects with Copiktra, including infections, diarrhea, intestinal and lung inflammation, skin responses, and elevated liver enzyme levels in the blood.
  • The risks and advantages of continuing to receive Copiktra, as well as possible alternative therapies, should be discussed with the doctor.
  • Every time one receives a Copiktra prescription, the patient Medication Guide should be read since the information may have changed. The Medication Guide outlines the most significant aspects of the medication. These include the adverse effects, the purpose of the medication, how to use and store it appropriately, and other things to be aware of when taking the medication.
  • Negative events from Copiktra or other drugs should be reported to the FDA MedWatch program to assist the FDA in tracking medication safety problems.
FDA step of action:

People react differently to all drugs based on their health, other medications they are taking, disorders they have, hereditary variables, and a variety of other factors. As a consequence, we cannot say how likely it is that someone may have these dangers while using Copiktra. To help the FDA track down pharmaceutical safety issues, they encourage patients and health care providers to report side effects from Copiktra or other medications to the FDA.

Patients should discuss the advantages and disadvantages of receiving Copiktra with their healthcare provider. While health care experts should weigh the risks and advantages of continuing Copiktra in the context of other available therapies, patients should talk to them about any questions or concerns they may have, including potential alternative treatments. Patients using Copiktra should be informed of the potentially elevated risk of mortality and elevated risk of life-threatening side effects. Even when used exactly as directed, all medications have dangers.

They are warning the public about these dangers, and they are still assessing how safe Copiktra is. Even a future public conference is being planned to debate the clinical study results and if Copiktra should still be supplied to patients. As soon as FDA has additional information, they will alert the public.

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