Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are types of slow-growing cancers that affect a type of white blood cell called a lymphocyte. Lymphocytes are cells that help your body fight infections. CLL and SLL cause your body to make too many lymphocytes that don’t work correctly. Both of these cancers are classified as Non-Hodgkin’s lymphoma, which is a group of cancers that affects white blood cells.
Brukinsa (BROO-kin-sah) was approved for CLL and SLL in 2023 and stops the growth and spread of cancer cells.
How Does It Work for CLL and SLL?
CLL and SLL are different forms of the same cancer. In CLL, the cancer cells are mainly found in the blood and bone marrow, which makes blood cells for your body. In SLL, the cancer cells are mainly found in your lymph nodes, which helps your body filter foreign substances, such as cancer cells.
There is no cure for CLL and SLL, but the disease can be managed with other treatment options such as medicine and chemotherapy. CLL and SLL have these symptoms:
- Pain, swelling, or fullness in your stomach
- Swelling of the lymph nodes in your neck, groin, or armpit
- Tiredness
- Shortness of breath
- Low red blood cell count (called anemia)
- Night sweats
- Weight loss
- Infections
Brukinsa falls into a group of medicines called targeted therapies. A targeted therapy is one that targets a specific protein inside cancer cells that helps stop the cancer cells from growing and spreading.
Brukinsa is a bruton tyrosine kinase (BTK) inhibitor. BTK is a protein that can cause cancer cells to grow. Brukinsa works to block the BTK protein, which helps stop the growth and spread of cancer cells.
How Do I Take It?
Brukinsa comes in 80-milligram capsules. The recommended dose is 160 milligrams (two capsules) twice a day or 320 milligrams (four capsules) once a day. Take Brukinsa as prescribed by your health care provider. Swallow the capsules whole with water. Do not open, break, or chew the capsules. Brukinsa can be taken with or without food.
How Was It Studied?
The safety and effectiveness of Brukinsa were studied in two clinical trials. In the first one, people either took Brukinsa or bendamustine and rituximab, which are medicines used for CLL/SLL. The study looked at progression-free survival, which is the amount of time it takes for your cancer to progress or get worse after you start a certain medicine. The median age (midpoint age of all the people in the study) of people in the study was 70 years old. The study included White people (90%), Asian or Pacific Islander people (3%), Black people (2%), and those classified as “not reported or unknown (7%).” These are averaged percentages across the groups of people.
In the second study, people either took Brukinsa or another BTK inhibitor for treating CLL/SLL called ibrutinib. The study looked at overall response, which is defined by how many people respond to the medicine. Specifically, it measures how many people had a partial or a complete response. Partial response is a decrease in the amount of cancer in your body. Complete response is when there are no signs of cancer in your body. The median age was between 67 to 68 years old. The study included White people (81%), Asian people (14%), Black people (1%), Native Hawaiian or Pacific Islander (0.5%), and those reported as “Multiple” (0.15%), “Other” (0.6%), “Not Reported” (3%), and “Unknown” (0.15%).
What Benefits Were Seen?
In the first study, the median progression-free survival was not reached. This means that because people in the study had a very long response to the medicine, it is not yet known how long it takes for at least half of the people to have their cancer progress. But an estimated 86% of people who received Brukinsa did not have their cancer progress by 24 months compared to 70% in the bendamustine-rituximab group.
In the second study, 84% in the Brukinsa group and 74% in the ibrutinib group had either a partial or complete response. The results showed that people taking Brukinsa had a higher overall response compared to people taking ibrutinib.
How Will I Know If It Is Working?
It may take some time to see how your body responds to Brukinsa. If you have symptoms due to your CLL or SLL, you may start to see them lessen or your condition start to stabilize. Your blood tests may also start to improve. Brukinsa can keep your CLL or SLL from worsening. Keep all appointments with your health care provider while taking Brukinsa. Call your health care provider if your symptoms worsen. Your health care provider can determine if they would like to add on another medicine or switch you to a completely different medicine.
What Are the Side Effects and How Can I Manage Them?
The most common side effects seen with Brukinsa are:
- A decrease in your neutrophils (a type of white blood cell) and platelets (help clot your blood)
- Infection in the nose or throat, sore throat, or common cold symptoms
- Bleeding
- Muscle or joint pain
Call your health care provider if you have any cold symptoms or muscle/joint pain. Your health care provider will tell you if you need any treatment for this, including if you need to keep over-the-counter medicines on hand.
Call your health care provider if you experience any signs of bleeding, such as:
- Pink, red, or brown urine (pee)
- Vomit with blood that looks like coffee grounds
- Red or black stools (looks like tar)
- Coughing up blood or blood clots
What Type of Drug Interactions Can Happen?
There are other medicines that can increase or decrease the blood levels of Brukinsa. These medicines are called cytochrome (CYP)3A inducers and inhibitors. These medicines can include clarithromycin, which is a medicine used to treat bacterial infections, and posaconazole, which is a medicine used to prevent fungal infections. Tell your health care provider about all the prescription, over-the-counter, and supplements you are taking. Your health care provider will determine if you are taking a CYP3A medicine.
What Do I Need to Do to Get It? Is There a Cost-Savings Program?
Brukinsa is available through a select network of specialty pharmacies. Talk to your health care provider to learn more. The manufacturer offers programs that can help with the cost of your Brukinsa prescription. You can find out more by visiting www.mybeigene.com/patient/program-services or by calling 833-234-4363.
