USFDA released a recent safety update for the duvelisib, which is used in the treatment of blood cancer – chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is a PI3 kinase inhibitor, which controls the multiplication and growth of cancer cells by blocking the signaling action of abnormal protein.
After the product approval in 2018, FDA asked drug manufacturer to conduct long term study for evaluating the safety of duvelisib (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). 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.
Important information for Healthcare professionals
To perform benefit-risk assessment in the context of other available treatments.
To advise patients on potential serious adverse effects.
To monitor patients for any sign/symptoms of side effects requiring early actions to implement for better patient safety.
Important information for Healthcare professionals
To be aware of this safety update and consider discussing any questions or concerns with your respective health care professional about the risks and benefits of receiving this medicine and about considering possible alternative treatments with better safety profile.
Copiktra (duvelisib) – For more product related information
Every medicinal product has both benefits and risks. Medicines are authorized to market based on the favorable benefit-risk profile anticipated at the time of regulatory approval/entry into market. However, the safety profile of medicine would continuously updates owing to safety data from the post marketing experience from public. If the rate of reporting of suspected adverse drug reactions (ADR) from public is line with the actual occurrence of ADRs, the time lapse for taking regulatory action can be reduced and thereby improving patient safety.
All health care professionals and consumers of pharmaceutical medicinal products are encouraged to be aware of this fact and observe/monitor for any possible adverse events, reactions, medication errors, or quality complaints of medicinal products and report the same to your respective national health authority.
This would accumulate safety evidence for medicinal products which in turn help health authorities to take regulatory actions at the earliest possibility for a better patient safety and overall public health.