According to a story from Rare Disease Report, the US Food and Drug Administration (FDA) has announced its approval of a combination therapy from Janssen which consists of ibrutinib plus obinutuzumab for patients with chronic lymphocytic leukemia who have yet to receive any prior treatment. This historic approval is the first combination for this disease that does not include chemotherapy.
About Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia is a form of blood cancer which affects lymphocytes, which are a type of white blood cell. The disease may not cause noticeable symptoms in its early stages. This cancer is linked to certain genetic mutations; notable risk factor for this blood cancer include old age, being male, exposure to certain insecticides, exposure to Agent Orange, and family history. Symptoms of chronic lymphocytic leukemia include fever, anemia, swollen lymph nodes, weight loss, and fatigue. It is also possible for this disease to transform into a more aggressive and faster progressing type of blood cancer like Hodgkin’s lymphoma. Treatment for this disease focuses mostly on controlling symptoms, and there is no cure. These treatments may include radiation therapy, chemotherapy, surgery, bone marrow transplant, or biological therapy. As a slow growing cancer, the five year survival rate is 83 percent. To learn more about chronic lymphocytic leukemia, click here.
A Chemotherapy Alternative
This approval also marks the tenth for ibrutinib, which is now indicated in six different areas of disease. It is useful for patients to have an alternative to chemotherapy, which has serious side effects that can take its toll on weaker or older patients. The combination is also available orally which is more convenient for chronic lymphocytic leukemia patients.
Encouraging Efficacy Data
The approval of ibrutinib and obinutuzumab was based on positive data from a Phase 3 clinical trial in which this combination fared better in comparison to the combination of chlorambucil plus obinutuzumab. The combination showed improved progression free survival and the risk of death or disease progression was reduced by 77 percent after a median follow-up period 31 months. The benefit was improved in patients with high risk disease, who saw their risk of death or progression reduced by 85 percent.
The combination does carry the risk of significant side effects, such as neutropenia, bleeding, rash, diarrhea, and muscle pain.
