People with mantle cell lymphoma (MCL) often need to try different treatments to control their cancer. MCL can be hard to treat because it is aggressive and usually not curable.
Jaypirca offers a new option for people with MCL. With targeted action on cancer cells, Jaypirca helps control the disease and extend the lives of those living with this rare condition.
How Does Jaypirca Work for Mantle Cell Lymphoma?
Mantle cell lymphoma (MCL) is a rare form of cancer that affects B cells. B cells are a type of white blood in your immune system. MCL is part of a larger group of cancers called non-Hodgkin's lymphoma. Non-Hodgkin's lymphoma includes over 60 different cancers that start in the lymph nodes.
MCL is usually aggressive, meaning it spreads and grows quickly. Health care providers may only diagnose MCL after the cancer has spread throughout the body. Common symptoms of MCL include:
- Swollen lymph nodes
- Fever
- Night sweats
- Weight loss
- General discomfort in the upper left side of your belly or back
Health care providers may also notice that your spleen is enlarged, causing discomfort. Blood tests might show abnormal levels of different blood cells, which is another sign of MCL.
MCL is hard to cure because it can be both aggressive and slow-growing. How long people survive with MCL depends on how aggressive the cancer is. The goal of treating MCL is to help people live longer. Your health care provider will choose medicines based on several things such as your age, the aggressiveness of your cancer, and your mantle cell international prognostic index (MIPI) score.
The MIPI helps health care providers determine your risk of dying from MCL. It considers your:
- Age
- Eastern Cooperative Oncology Group (ECOG) performance status
- Level of lactate dehydrogenase (LDH) in your blood
- White blood cell count
Older age and higher levels of LDH or white blood cells are usually linked to worse outcomes. The ECOG performance status tells health care providers how well a person with a serious disease can tolerate treatment.
Health care providers may prescribe Jaypirca to treat MCL in adults when the cancer has come back (relapsed) or has not responded to two previous treatments (refractory). Jaypirca contains the medicine pirtobrutinib, which is a kinase inhibitor. It blocks a specific protein in B cells called Bruton’s tyrosine kinase (BTK). When Jaypirca blocks BTK, cancer cells stop growing.
How Do I Take Jaypirca?
Jaypirca comes as an oral tablet that you take once a day with a glass of water. You can take Jaypirca with or without food but always at around the same time each day. It is also a coated tablet, so you will swallow Jaypirca whole. The tablet cannot be cut, crushed, or chewed.
If you miss a dose of Jaypirca, take it as soon as you remember. However, if you missed your dose by more than 12 hours, skip the missed dose and take the next one at your usual time.
Your health care provider will keep you on Jaypirca until your cancer starts to spread and grow again. If you have certain side effects from Jaypirca, such as changes in your blood cell count levels, your health care provider may temporarily pause your treatment or lower the dose. If your side effects are severe and you cannot tolerate them, your health care provider may tell you to stop taking Jaypirca.
If you have or develop kidney problems, your health care provider may prescribe a lower dose of Jaypirca.
How Was It Studied for Mantle Cell Lymphoma?
An international clinical trial looked at how Jaypirca helped people with MCL. The study included 120 people with relapsed or refractory MCL who previously received a BTK inhibitor that did not work to treat their disease. The people could also have other B-cell cancers and be included in the study.
The study included people between 46 and 87 years old. Most of the people in the study were male (80%). Nearly 78% had moderate to high-risk MCL based on the MIPI score. Each person in the study took Jaypirca until their cancer got worse, they had to stop treatment because of side effects, or they chose to leave the study.
To check the effectiveness of Jaypirca, researchers evaluated results from the first 90 people enrolled in the study:
- Overall response rate (ORR): The ORR gives the percentage of people whose cancer disappeared or shrunk.
- Duration of response (DOR): The DOR is a measure of the time from the start of the study until death or the first signs of cancer progressing (spreading) or getting worse among those who had a response.
- Overall survival (OS): The OS is the time from the start of the study until the people died.
- Progression-free survival (PFS): The PFS is the time from the start of the study until death or the first evidence of disease progression.
What Were the Benefits?
Cancer improvement or resolution. Over half of the people in the study saw their cancer improve or disappear with Jaypirca in positron emission tomography (PET) and computed tomography (CT) body scans. The overall response rate (ORR) was 57.8%, meaning that over half of people in the study responded to the treatment. This includes 20% of people whose cancer was completely gone and nearly 40% who experienced a partial response. A partial response occurs when the cancer shrinks by more than 30%, but has not disappeared.
Long-lasting response. The effect of Jaypirca was long-lasting for many people. The median duration of response was 21.6 months. This means that half of those who responded had their cancer stay controlled for less than 21.6 months, while others saw benefits past 21.6 months.
Progression-free survival. In the clinical study, the median progression-free survival was 7.4 months. This means that in half of the people, the cancer worsened or they passed away in less than 7.5 months, while the other half went longer than 7.4 months without their cancer getting worse.
Overall survival. At the end of the study, many people were still alive. After 12 months of the study, about 70% of people were still living. After 18 months, just under 60% were still alive.
How Long Does It Take for Jaypirca to Work?
Jaypirca starts to work as soon as you start your treatment. However, you and your health care provider may only see its benefits after several months.
To check if your cancer worsened, shrunk, or disappeared with Jaypirca, your health care provider will use scans of your tumor or blood tests.
How Can I Prevent and Manage Side Effects?
The most common side effects of Jaypirca include tiredness, muscle and bone pain, diarrhea, infections, bruising, and cough. It can also cause changes in your blood test results.
Since Jaypirca can cause tiredness, do not drive or do other activities that require alertness or coordination until you know how the medicine affects you.
To prevent dehydration from diarrhea, drink plenty of water with electrolytes. Limit high-fiber and sugary foods. To improve diarrhea with Jaypirca, eat foods like bananas, toast, oatmeal, white rice, applesauce, and broth.
Infections such as COVID-19 are also common with Jaypirca. The CDC recommends several strategies to prevent infections, such as:
- Handwashing
- Nail grooming
- Facial cleanliness
- Covering coughs and sneezes with a tissue or inside of the elbow
You can prevent some infections with vaccination. People with a high risk of infection may need antibiotics or other medicines to prevent infections.
If you notice that you have bruises on your body, tell your health care provider right away. This may be a sign of severe bleeding, which can happen with Jaypirca, even if you are not taking blood thinners.
To manage muscle and bone pain, ask your doctor or pharmacist before you take any over-the-counter medicine.
While you cannot prevent changes in your blood test results with Jaypirca, your health care provider will check your blood counts regularly during treatment. If needed, your health care provider may lower, pause, or completely stop Jaypirca.
These are not all the possible side effects of Jaypirca. Talk with your health care provider if you are having symptoms that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What Kinds of Drug Interactions Can Happen?
Some medicines can alter the blood levels of Jaypirca due to their action on the liver. These drug interactions can reduce or increase the effects of Jaypirca. In certain cases, these effects are so significant that these medicines should not be taken together. If you cannot avoid drug interactions, your health care provider may change your dose of Jaypirca.
Examples of medicines that may interact with Jaypirca include:
- Clarithromycin and rifampin, which are antibiotics used to treat certain infections
- Itraconazole, which is used to treat fungal infections
- Carbamazepine and phenytoin, which are used to control seizures and treat epilepsy
- Verapamil, which is typically used to treat blood pressure, angina, and irregular heartbeat
Do not drink grapefruit juice during treatment with Jaypirca. If you take Jaypirca and drink grapefruit juice, you can increase your risk of developing serious muscle problems.
Since severe bleeding may happen with Jaypirca, tell your health care provider if you are taking blood thinner medicines.
This is not a complete list of medicines that may interact with Jaypirca. Tell your pharmacist or health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them determine if there are any interactions with Jaypirca or if you need a dosage adjustment. Talk to your health care provider about all your medical conditions.
What Are Other Unique Considerations to Be Aware Of?
Jaypirca can harm a fetus. If you can become pregnant, you must use effective birth control during treatment with Jaypirca and up to one week after your last dose.
Some people may develop an irregular heartbeat during treatment with Jaypirca. If you have high blood pressure or an irregular heartbeat, your risk may be higher. Tell your health care provider if you have any of the following symptoms:
- Fast heartbeat
- Dizziness
- Fainting
- Chest pain or discomfort
- Difficulty breathing
Jaypirca may harm your liver. Your health care provider will order blood tests to check how well your liver works before and during treatment with Jaypirca. If you show signs of liver problems with Jaypirca, your health care provider may check your liver function more often. Your health care provider may tell you to pause or stop Jaypirca if you develop severe liver problems.
Jaypirca may also cause skin problems, including skin cancer. To lower your risk of skin problems with Jaypirca:
- Seek shade when outside between 10 a.m. and 4 p.m.
- Cover your skin with long pants, sleeves, and a broad-brimmed hat.
- Use sunscreen with UVA and UVB protection.
Your health care provider will routinely check you for skin cancer and other cancers during treatment with Jaypirca.
Your health care provider will do a pregnancy test before starting treatment with Jaypirca to make sure you are not pregnant.
Since Jaypirca can cause bleeding, tell your health care provider about any planned surgeries or dental procedures. Your health care provider may tell you to pause Jaypirca to prevent major bleeding.
Is There Any Cost Assistance Available?
You can find a savings card from the manufacturer of Jaypirca. The savings card may allow you to pay as little as $0 for your prescription. You may be eligible for this savings coupon if you have private drug insurance. You can read more about the savings coupon at www.jaypirca.lilly.com/savings-support.
