Chronic lymphocytic leukemia (CLL) is a type of blood cancer that affects white blood cells called lymphocytes. There are many types of leukemia, and CLL is a common type in adults.
This type of cancer starts in the bone marrow and then goes into the blood. In people with CLL, the bone marrow makes large numbers of lymphocytes that do not work properly. These abnormal cells can crowd out healthy cells, which can cause infection, anemia, or make you bleed easily. They can also spread to other parts of the body.
Often people do not have any symptoms of CLL for many years after the disease starts because it develops slowly. Symptoms of CLL may begin to appear as it spreads to the lymph nodes, liver, spleen, or other areas in the body.
Because CLL develops slowly, you may not need to be treated right away. You will work with your health care provider to find out when treatment is right for you. Your health care provider has many options for treating your CLL, including chemotherapy, immunotherapy, and targeted therapy. Zydelig is a targeted therapy for CLL.
How Does Zydelig Work for Chronic Lymphocytic Leukemia?
Zydelig (idelalisib) targets cells in the immune system known as B cells. In people with CLL, B cells can become cancerous. Zydelig helps slow down or stop the growth of cancerous B cells. It does this in a few ways:
- Blocking signals that cancer cells use to grow
- Causing the death of cancer cells
- Preventing cancer cells from spreading
- Making it harder for cancer cells to stick to other cells or spread
How Do I Use Zydelig for Chronic Lymphocytic Leukemia?
Zydelig is an oral tablet that you should take twice a day. You may take it with or without food. You should swallow the tablets whole and should not cut, crush, or chew them.
Your health care provider may adjust your dose if you have any side effects or changes in liver enzymes or bilirubin. Your health care provider may temporarily or permanently stop Zydelig if you get certain side effects.
Is Zydelig Right for Me?
Zydelig should not be used in people who have had a serious allergic reaction to it in the past. It should also not be used in people who have had a history of toxic epidermal necrolysis caused by any other medicine.
Zydelig should only be used after other treatments for CLL have not worked.
How Was Zydelig Studied for Chronic Lymphocytic Leukemia?
How was the study designed?
Zydelig was studied in 220 people with CLL that had gotten worse within two years of their last treatment. People in this study were not able to use other chemotherapy medicines because of serious side effects, other illnesses, or kidney problems. In order to be in this study, people had to have been treated with at least two previous chemotherapy regimens or with regimens that contain a medicine class called CD20 antibodies.
People in this study took either intravenous rituximab (given as an infusion into a vein) plus oral Zydelig 150 mg twice daily or intravenous rituximab plus an oral placebo pill. Placebo pills do not contain an active medicine.
To see if Zydelig worked, the researchers looked at progression-free survival (PFS). PFS measures how long a person lives before their disease gets worse (progresses) after they start treatment. The PFS in the rituximab plus Zydelig group was compared to the PFS in the rituximab plus placebo group. They also looked at overall response rate, which is the number of people who had a complete response to treatment.
To see if Zydelig was safe, the researchers collected information on what types of side effects people had during the study.
What types of people were included in the study?
About 78% of people in this study were at least 65 years of age. Almost two-thirds of the people had advanced-stage disease. The median time since CLL diagnosis was about nine years. The median number of prior therapies was three.
What are the main benefits of Zydelig based on this study?
At the end of the study, the PFS was 19.4 months in the rituximab plus Zydelig group. The PFS was 6.5 months in the rituximab plus placebo group.
The overall response rate was about 84% in the rituximab plus Zydelig group, compared to about 16% for the rituximab plus placebo group.
The most common side effects reported by people taking rituximab plus Zydelig were fever, tiredness, nausea, chills, and diarrhea. Also common were decreases in white blood cells and increases in liver enzymes, which can happen when the liver is inflamed or damaged.
Your results may differ from what was seen in clinical studies.
How Do I Know if Zydelig Is Working?
You may not see changes right away. It may take weeks to months before your health care provider can tell if Zydelig is working for you. Your health care provider will look at blood tests, biopsies, and scans to find out if it is working for you.
Is There Any Cost Assistance Available for Zydelig?
Zydelig is only available through a special program, from certain pharmacies, and to certain people.
There may be cost assistance to help you afford Zydelig. You may have options even if you do not have health insurance. Your health care provider can help you get started, or you can call Zydelig AccessConnect at 844-622-2377.
