Jaypirca: The Breakthrough Drug for Mantle Cell Lymphoma

As the first FDA-approved non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for relapsed or refractory mantle cell lymphoma (MCL), Jaypirca (pirtobrutinib) represents a significant advancement in the fight against this rare and aggressive blood cancer. This breakthrough medication for MCL is offering new hope to patients who have exhausted other treatment options. 

This article will give you an in-depth review of Jaypirca’s impact on MCL treatment, how it works, its associated risks, and what precautions should be taken before or during the treatment.

What Is Jaypirca?

Jaypirca is an anticancer medication, also known by the name of the active component it contains: pirtobrutinib. This medication was recently granted accelerated approval by the FDA on January 27, 2023, for treating refractory or relapsed mantle cell lymphoma (MCL), a form of non-Hodgkin’s lymphoma (NHL), in adult patients. As an accelerated approval medication, Jaypirca fills a medical need for MCL that other medication therapies currently do not meet.  However, in order to obtain regular FDA approval, the drug company must complete clinical trials to further confirm the clinical benefit of this medication.

Jaypirca (pirtobrutinib) belongs to the drug class called “BTK inhibitors,” which block the activity of the BTK enzyme and inhibit the abnormal growth of B-cells in MCL. Jaypirca is unique in that it is a non-covalent inhibitor, whereas other treatments for MCL on the market are covalent inhibitors. As a non-covalent inhibitor, Jaypirca targets specific BTK mutations that are becoming resistant to the covalent inhibitors.

What Is Jaypirca Used To Treat?

Jaypirca is used to treat refractory or relapsed mantle cell lymphoma (MCL) in adult patients whose cancer has returned or stopped responding to previous treatments and who have received at least two or more prior therapies, including covalent BTK medicines. 

Mantle cell lymphoma (MCL) is a type of blood cancer affecting the lymphatic system and is thought to arise from genetic mutations or changes that occur in B cells, a type of white blood cell that helps the body to fight infection. In MCL, these genetic changes cause the B cells to grow and divide uncontrollably, leading to the formation of a mass of abnormal cells (tumors) in the lymphatic system. MCL usually develops in the lymph nodes but can also spread to other organs, such as the bone marrow, spleen, and gastrointestinal tract.

MCL is a relatively rare type of non-Hodgkin’s lymphoma (NHL), accounting for about 6% of all NHL cases.

How Does Jaypirca Work?

Jaypirca contains an active substance, “pirtobrutinib,” which acts as a non-covalent BTK inhibitor and blocks the activity of the BTK enzyme. BTK enzyme is a key component of the B-cell receptor (BCR) signaling pathway, which is essential for the development and function of B cells, a type of white blood cell. 

Generally, in MCL, cancerous B cells overproduce BTK enzymes, leading to the uncontrolled growth and proliferation of these cells. 

Mode of Action

Jaypirca reversibly inhibits the BTK enzyme activity, disrupts the BCR signaling pathway, and interferes with B cell activation and proliferation. This leads to a reduction in the number of cancerous B cells and slows down the progression of the disease.

Jaypirca is highly selective for BTK and has a unique binding profile that differentiates it from other BTK inhibitors. This selective binding provides greater efficacy and safety in the treatment of MCL.

It is important to note that the exact mechanism of action of Jaypirca in the treatment of MCL is still being studied, and further research is needed to fully understand the drug’s effects on cancerous B cells.

Jaypirca Dosage Form and Strength

Jaypirca is currently available in 50 mg and 100 mg tablets. Jaypirca is well tolerated and is only available with a doctor’s prescription. 

Dosing Information

The initial recommended dose for adults with MCL is 200 mg (two 100 mg tablets) once a day. However, the dosage of Jaypirca can be adjusted according to the patient’s health status. For example, if you have severe kidney impairment, take certain medications, or if you are experiencing an adverse reaction from your current dose of Jaypirca, your doctor may change the dose to decrease side effects. 

Overdose 

Avoid taking a double dose of Jaypirca to compensate for a missed dose. If you have missed your dose by more than 12 hours, skip that dose and take the next scheduled dose at your regular time prescribed by your doctor. 

How Is Jaypirca Used?

Jaypirca tablet is taken orally (by mouth). You can take a Jaypirca tablet with or without food. The tablet should be swallowed and not chewed, crushed, or cut. 

Possible Side Effects

The possible common side effects that are clinically reported in ≥ 15% of MCL patients after taking Jaypirca include:

• Tiredness or fatigue
• Diarrhea
• Pneumonia
• Musculoskeletal pain (muscle, bone, and joint pain)
• Swelling and bruising
• Shortness of breath (dyspnea)

Moreover, the less common or rare adverse reactions include:

• Infections (including bacterial, viral, or fungal infections)
• Bleeding problems (including blood in urine, stool, or vomiting blood)
• Decreased blood cell counts (including neutropenia, anemia, and thrombocytopenia)
• Atrial fibrillation and flutter (abnormal heartbeats or chest discomfort)
• Second primary malignancies (new cancers of the skin or other organs)

What Drugs Should You Avoid While Taking Jaypirca?

Other drugs may interact with Jaypirca and can reduce its effectiveness. It is important to tell your doctor about all medications you are taking, including both prescription and over-the-counter (OTC) medications. The following are some of the reported drugs that may affect the working mechanism of Jaypirca and increase the risk of side effects:

• Strong CYP3A inhibitors (itraconazole) and inducers (rifampin and St. John’s wort)
• Moderate CYP3A inducers (efavirenz and bosentan) and inhibitors (verapamil and diltiazem)

Precaution While Taking Jaypirca

Do not take Jaypirca if you are:

• Pregnant or planning to become pregnant. Jaypirca may cause fetal harm, as per animal studies. 
• Breastfeeding or planning to breastfeed. Since it is unknown whether this drug secretes in human breast milk or not, it is recommended to avoid breastfeeding while taking Jaypirca and for 1 week after your last dose. 

Moreover, tell your healthcare provider if you:

• Have high blood pressure 
• Have a history of cancer
• Have or had heart rhythm problems
• Have bleeding disorders or are taking anticoagulants
• Have kidney problems
• Have had surgery recently or plan to have surgery
• Have an infection or are prone to infections

Costo

The estimated U.S. wholesale acquisition cost of the Jaypirca will be $21,000 for 1 month (30 days) of therapy with a 200 mg daily dose. However, the official distribution pricing will be available in the U.S. later this quarter. Contact us if you are interested in receiving financial assistance for Jaypirca.