The United States Food and Drug Administration has approved Copiktra™ (duvelisib). The drug is now approved as a treatment for adult patients diagnosed with refractory or relapsed chronic lymphocytic leukaemia or small lymphocytic lymphoma that have received two or more prior therapies. In addition, Copiktra™ was also approved under Accelerated Approval as a treatment for adults with relapsed or refractory follicular lymphoma (FL) that have had at least two prior systemic therapies. However, more information about the drug’s effects in patients with FL may need to be gathered in order for approval to continue. To read about this news in more detail you can click here to view the source press release at Business Wire. To find out more about Copiktra™, click here.
About Chronic Lymphocytic Leukaemia (CLL)
CLL is a common form of leukaemia that is more common in older people and generally develops slowly. It is a cancer that occurs when the bone marrow makes too many white blood cells that aren’t fully developed and don’t work properly. Over time, these can build up and affect other cells, such as red blood cells, functional white blood cells, and platelets.
About Small Lymphocytic Lymphoma (SLL)
SLL is a form of non-Hodgkin lymphoma that is similar to CLL. Often, it is a slow growing cancer. SLL develops when the body produces abnormal B-cells (a type of white blood cell). These can build up, and may cause swelling.
Research into Copiktra™ (Duvelisib) for CLL/SLL
A trial compared the effects of Copiktra to ofatumumab (a cancer drug) in 319 adult patients who had CLL or SLL and had tried one or more prior therapies. Approval of Copiktra was based on a subset of this group that had had at least two prior therapies. Within this subset, 80% of patients were given Copiktra for at least 6 months, and just over half (52%) were given it for one year or more. The overall response rate for patients taking Copiktra was found to be 78%, compared to 39% for patients taking ofatumumab.
Copiktra™ and Follicular Lymphoma (FL)
Follicular Lymphoma is a form of non-Hodgkin lymphoma that is the result of the body creating abnormal B-cells. Copiktra has been granted accelerated approval as a treatment for adults with relapsed or refractory FL who have received two or more prior systemic therapies. This decision was based on research into the overall response rate, but continued approval could depend on more information from confirmatory trials.
Copiktra is associated with serious side effects, which you can find out more about here.