Jaypirca: Uses, Dosage & Side Effects
A non-covalent (reversible) Bruton's tyrosine kinase inhibitor for the treatment of relapsed or refractory mantle cell lymphoma and chronic lymphocytic leukemia in adults previously treated with a BTK inhibitor
Jaypirca (pirtobrutinib) is a prescription cancer medication used to treat certain types of blood cancers in adults who have previously received another Bruton's tyrosine kinase (BTK) inhibitor. Specifically, it is approved for relapsed or refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). Jaypirca is the first non-covalent (reversible) BTK inhibitor, meaning it can maintain efficacy even when tumors have developed resistance to earlier-generation covalent BTK inhibitors such as ibrutinib, acalabrutinib, or zanubrutinib. Taken as a once-daily oral tablet at a dose of 200 mg, Jaypirca works by blocking the BTK protein that cancer cells depend on for growth and survival. Clinical trials have demonstrated meaningful overall response rates in heavily pre-treated patients, offering a new treatment option where previously few existed.
Quick Facts: Jaypirca
Key Takeaways
- Jaypirca (pirtobrutinib) is the first non-covalent (reversible) BTK inhibitor, designed to overcome resistance to covalent BTK inhibitors like ibrutinib, acalabrutinib, and zanubrutinib by binding to BTK without forming a permanent bond.
- It is approved as monotherapy for adults with relapsed or refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) who have previously been treated with another BTK inhibitor.
- The recommended dose is 200 mg taken orally once daily, with or without food. Tablets should be swallowed whole and not chewed, crushed, or split.
- Common side effects include fatigue, infections, neutropenia, diarrhea, bruising, nausea, anemia, joint pain, thrombocytopenia, rash, and abdominal pain. Regular blood count monitoring is essential during treatment.
- Jaypirca should not be used during pregnancy or breastfeeding. Women of childbearing potential must use effective contraception during treatment and for 5 weeks after the last dose; men must use contraception for 3 months after the last dose.
What Is Jaypirca and What Is It Used For?
Jaypirca contains the active substance pirtobrutinib, a highly selective, non-covalent inhibitor of Bruton's tyrosine kinase (BTK). BTK is a critical enzyme in the B-cell receptor (BCR) signaling pathway, which plays a central role in the growth, proliferation, and survival of both normal and malignant B lymphocytes. In cancers such as mantle cell lymphoma and chronic lymphocytic leukemia, the BCR signaling pathway is often constitutively activated, driving the uncontrolled growth of malignant B cells. By blocking BTK, pirtobrutinib disrupts this signaling cascade and thereby inhibits the proliferation of cancer cells, promotes their programmed death (apoptosis), and reduces their ability to migrate and adhere to supportive tissues in the bone marrow and lymph nodes.
What sets Jaypirca apart from earlier-generation BTK inhibitors is its non-covalent binding mechanism. The first three BTK inhibitors approved for clinical use — ibrutinib, acalabrutinib, and zanubrutinib — all work by forming a permanent (covalent) bond with a specific amino acid residue (C481) in the active site of BTK. While these covalent BTK inhibitors have transformed the treatment landscape for B-cell malignancies, a significant proportion of patients eventually develop resistance through a point mutation at the C481 binding site (most commonly C481S). This mutation prevents the covalent bond from forming, rendering these drugs ineffective. Pirtobrutinib was specifically designed to overcome this limitation. Because it binds to BTK through non-covalent (reversible) interactions that do not depend on the C481 residue, it retains full inhibitory activity against both wild-type BTK and the C481S mutant form. This makes Jaypirca a critically important option for patients whose disease has progressed on or after treatment with a covalent BTK inhibitor.
Mantle Cell Lymphoma (MCL)
Mantle cell lymphoma is a relatively uncommon but often aggressive form of non-Hodgkin lymphoma arising from B cells in the mantle zone of lymph nodes. It accounts for approximately 3–6% of all non-Hodgkin lymphomas, with an estimated incidence of 0.5–1 per 100,000 people per year. MCL predominantly affects older adults (median age at diagnosis around 65–70 years) and is more common in men than women. Despite improvements in frontline therapy, MCL remains difficult to cure, and most patients will experience relapse at some point during their disease course. BTK inhibitors, particularly ibrutinib, represented a major advance in relapsed or refractory MCL, but resistance eventually develops in many patients. Jaypirca provides a much-needed treatment option for these patients.
The approval of Jaypirca for relapsed or refractory MCL was based on the BRUIN clinical trial, a multicenter, open-label, phase 1/2 study. In the MCL cohort of this trial, patients who had received at least two prior lines of therapy (including a covalent BTK inhibitor) were treated with pirtobrutinib 200 mg once daily. The results demonstrated an overall response rate (ORR) of approximately 50–57%, with a complete response rate of 13–20%. Notably, responses were observed regardless of the reason for discontinuation of the prior BTK inhibitor (whether due to disease progression, intolerance, or other reasons) and regardless of the presence of the C481S mutation. The median duration of response was approximately 8–12 months, providing meaningful clinical benefit in this heavily pre-treated patient population.
Chronic Lymphocytic Leukemia (CLL)
Chronic lymphocytic leukemia is the most common adult leukemia in Western countries, with an incidence of approximately 4–5 per 100,000 people per year. CLL is a cancer of mature B lymphocytes that accumulate in the blood, bone marrow, lymph nodes, and spleen. The clinical course of CLL is highly variable, ranging from indolent disease that may never require treatment to aggressive forms that necessitate multiple lines of therapy. BTK inhibitors have become a cornerstone of CLL treatment, used both as frontline therapy and in the relapsed or refractory setting. However, as with MCL, acquired resistance (particularly through the C481S mutation) represents a significant clinical challenge.
In the BRUIN trial, patients with relapsed or refractory CLL who had previously received a covalent BTK inhibitor were treated with pirtobrutinib. The results were encouraging, with an overall response rate of approximately 73% (including partial responses with lymphocytosis, a common initial finding with BTK inhibitors in CLL). Responses were durable, and the treatment was well tolerated. These results led to the approval of Jaypirca for this indication. The pivotal phase III BRUIN CLL-321 trial, comparing pirtobrutinib to investigator's choice of idelalisib plus rituximab or bendamustine plus rituximab in BTK inhibitor pre-treated CLL patients, further supports its use in this setting.
Jaypirca blocks Bruton's tyrosine kinase (BTK), a protein that cancer B cells need to grow and survive. Unlike earlier BTK inhibitors that permanently bind to the enzyme (covalent binding), Jaypirca uses a reversible binding approach. This means it can still work effectively even when cancer cells have developed the C481S resistance mutation that makes older BTK inhibitors ineffective. This novel mechanism represents a significant advance in the treatment of relapsed B-cell malignancies.
What Should You Know Before Taking Jaypirca?
Contraindications
The primary contraindication for Jaypirca is hypersensitivity (allergy) to the active substance pirtobrutinib or to any of the excipients listed in the formulation. If you have a known allergy to any of the tablet components — which include hypromellose acetate succinate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, colloidal hydrated silicon dioxide, hypromellose, titanium dioxide, triacetin, and indigo carmine (E132) — you should not take this medication. If you experience signs of an allergic reaction such as itchy raised rash (hives), difficulty breathing, or swelling of the face, lips, tongue, or throat while taking Jaypirca, stop taking the medication immediately and seek urgent medical attention.
Warnings and Precautions
Before starting treatment with Jaypirca, it is essential to have a thorough discussion with your healthcare provider about your medical history and any current health conditions. Several important warnings and precautions apply to the use of this medication:
Jaypirca can increase your risk of serious infections, including pneumonia, upper respiratory tract infections, and urinary tract infections. Some of these infections can be life-threatening. Contact your doctor immediately if you develop fever, chills, weakness, body aches, cough, cold or flu-like symptoms, confusion, tiredness, shortness of breath, or painful urination. These may be signs of infection that require prompt medical treatment.
- Infections: Tell your doctor if you have an active infection or are at increased risk of opportunistic infections (infections that occur more easily in people with weakened immune systems). Your doctor may prescribe medications to prevent or treat infections before and during your Jaypirca treatment. Infections are among the most common side effects of Jaypirca and can sometimes be severe.
- Bleeding: Jaypirca may increase the risk of bleeding, including bruising and hemorrhage. Inform your doctor if you have any history of unusual bruising or bleeding, or if you take medications or supplements that may increase bleeding risk (such as anticoagulants, antiplatelet agents, NSAIDs, or supplements like fish oil, vitamin E, or flaxseed). Your doctor will monitor you for signs and symptoms of bleeding during treatment.
- Low blood cell counts (cytopenias): Jaypirca can cause decreases in neutrophils (white blood cells that fight infection), red blood cells (leading to anemia), and platelets (cells that help blood clot). If you have recently had low blood counts, inform your doctor. Regular blood tests will be performed during treatment to monitor your blood cell levels, and your doctor may adjust or temporarily pause your dose if counts become too low.
- Surgery: If you are planning to have surgery or a dental procedure, tell your surgeon or dentist that you are taking Jaypirca. Your doctor may ask you to stop taking the medication for 3 to 5 days before and after the procedure to reduce the risk of bleeding.
- Heart rhythm problems: Jaypirca may cause or worsen irregular heartbeats (cardiac arrhythmias), including atrial fibrillation and atrial flutter. Tell your doctor if you have or have ever had heart rhythm disorders, high blood pressure, a previous heart attack, or damaged heart valves. Your doctor may monitor your heart rhythm during treatment.
- Skin cancer: Treatment with Jaypirca may increase the risk of certain types of skin cancer. Use sunscreen regularly and examine your skin periodically for any new or changing lesions. Report any skin changes to your doctor.
- Tumor lysis syndrome (TLS): In rare cases, the rapid breakdown of cancer cells during treatment can lead to a condition called tumor lysis syndrome, which may cause kidney failure, irregular heartbeats, or seizures. Your doctor may perform blood tests to monitor for TLS, particularly at the start of treatment.
Children and Adolescents
Jaypirca is not approved for use in children and adolescents under 18 years of age. The safety and efficacy of pirtobrutinib have not been studied in this age group. Mantle cell lymphoma and chronic lymphocytic leukemia are overwhelmingly diseases of adults, and pediatric dosing recommendations are not available. If you are a caregiver of a young person with a B-cell malignancy, consult with a pediatric oncologist about appropriate treatment options.
Pregnancy and Breastfeeding
Jaypirca must not be used during pregnancy. Based on its mechanism of action, pirtobrutinib may cause harm to an unborn baby. If you are a woman of childbearing potential, you must use effective contraception during treatment and for at least 5 weeks after the last dose of Jaypirca. If you are a man whose partner could become pregnant, you must use effective contraception during treatment and for at least 3 months after the last dose. Contact your doctor immediately if you or your partner becomes pregnant during treatment.
Breastfeeding is not recommended during treatment with Jaypirca and for at least one week after the last dose. It is not known whether pirtobrutinib passes into breast milk, and a risk to the nursing infant cannot be excluded. The decision about whether to breastfeed or continue Jaypirca treatment should be made in consultation with your doctor, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.
The effects of pirtobrutinib on fertility are not fully known. If you are planning to have children, discuss this with your doctor or pharmacist before starting treatment.
Driving and Operating Machinery
Jaypirca may have a minor effect on the ability to drive and operate machinery. You may experience fatigue, dizziness, or weakness while taking this medication, which could impair your ability to drive or use machines safely. If you experience any of these effects, avoid driving or operating machinery until you feel well enough to do so safely.
Important Information About Ingredients
Jaypirca film-coated tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medication.
Jaypirca contains less than 1 mmol (23 mg) of sodium per daily dose of 200 mg, meaning it is essentially sodium-free. This is relevant for patients on a sodium-restricted diet.
How Does Jaypirca Interact with Other Drugs?
Unlike monoclonal antibodies that are cleared through general protein catabolism, pirtobrutinib is a small molecule that is metabolized and can interact with other drugs through pharmacokinetic and pharmacodynamic mechanisms. It is important to inform your healthcare provider about all prescription medications, over-the-counter drugs, herbal supplements, and dietary supplements you are currently taking or plan to take during your treatment with Jaypirca.
Medications That Increase Bleeding Risk
Jaypirca may increase the tendency to bleed. This means that taking it together with other medications or supplements that also increase bleeding risk can compound this effect. You should inform your doctor if you are taking any of the following:
- Aspirin and NSAIDs such as ibuprofen and naproxen
- Anticoagulants (blood thinners) such as warfarin, heparin, and other medications for the treatment or prevention of blood clots
- Dietary supplements that may increase bleeding risk, such as fish oil, vitamin E, or flaxseed
Medications Affected by Jaypirca
Jaypirca can affect how well certain other medications work by altering their metabolism or transport in the body. The following table summarizes the key drug interactions identified with pirtobrutinib:
| Drug / Class | Used For | Interaction Type | Clinical Significance |
|---|---|---|---|
| Repaglinide, rosiglitazone, pioglitazone | Diabetes | Jaypirca may alter efficacy | Monitor blood glucose closely |
| Rosuvastatin | High cholesterol | Increased statin exposure | Monitor for muscle pain and liver enzymes |
| Digoxin | Heart disease | Increased digoxin levels | Monitor digoxin levels; dose adjustment may be needed |
| Dabigatran etexilate | Blood clot prevention | Increased dabigatran exposure | Increased bleeding risk; monitor closely |
| Midazolam | Sedation | Altered midazolam metabolism | Monitor for increased sedation |
| Methotrexate | Cancer, autoimmune diseases | Increased methotrexate levels | Monitor for methotrexate toxicity |
| Rifampicin | Tuberculosis | May reduce pirtobrutinib levels | Avoid concomitant use if possible |
| Tacrolimus | Organ transplant rejection | Altered tacrolimus levels | Monitor tacrolimus blood levels |
| Phenobarbital, phenytoin, carbamazepine | Seizures / Epilepsy | May reduce pirtobrutinib levels | Discuss alternatives with your doctor |
| Montelukast | Asthma | Jaypirca may alter efficacy | Monitor asthma control |
Additionally, pirtobrutinib may interact with selexipag (used for pulmonary arterial hypertension), dasabuvir (used for hepatitis C), alfentanil (used in anesthesia), and mitoxantrone (used for other cancers). Always provide your healthcare team with a complete list of all medications and supplements you take, including over-the-counter products and herbal remedies, before starting treatment and at every clinic visit.
Strong CYP3A inducers such as rifampicin, phenobarbital, phenytoin, and carbamazepine may significantly reduce pirtobrutinib blood levels, potentially decreasing its anticancer efficacy. Discuss with your oncologist before starting any new medications while on Jaypirca treatment.
What Is the Correct Dosage of Jaypirca?
Always take Jaypirca exactly as your doctor or pharmacist has directed. Do not change your dose or stop taking the medication without first consulting your healthcare provider. Treatment with Jaypirca is typically continued for as long as the cancer responds to the medication and the side effects remain manageable.
Adults
| Parameter | Details |
|---|---|
| Recommended dose | 200 mg once daily |
| Tablet strengths available | 50 mg and 100 mg film-coated tablets |
| Administration | Oral, swallow whole with water |
| Food requirement | Can be taken with or without food |
| Timing | At approximately the same time each day |
| Treatment duration | Continue until disease progression or unacceptable toxicity |
The standard 200 mg daily dose can be achieved using four 50 mg tablets or two 100 mg tablets. Your pharmacist will dispense the appropriate tablet strength based on your prescription. It is important to take the tablets at approximately the same time every day to maintain consistent drug levels in your body. The tablets can be taken with or without food, giving you flexibility in your daily routine.
If you experience certain side effects during treatment, your doctor may temporarily pause your Jaypirca therapy or reduce the dose. Dose reductions are typically managed in a stepwise fashion, and your doctor will guide you on when and how to resume treatment. Do not adjust the dose on your own without medical guidance.
Children and Adolescents
Jaypirca is not approved for use in patients under 18 years of age. The safety and efficacy of pirtobrutinib have not been established in the pediatric population, and no dosing recommendations are available for children or adolescents.
Elderly Patients
No dose adjustment is required solely based on age. The clinical trials that led to the approval of Jaypirca included a significant proportion of elderly patients, as both MCL and CLL predominantly affect older adults. The safety and efficacy profile of pirtobrutinib in older patients was generally consistent with that observed in younger patients. However, elderly patients may be more susceptible to certain side effects such as infections and cytopenias, and careful monitoring is advisable.
Missed Dose
What to Do If You Miss a Dose
- Less than 12 hours late: Take the missed dose immediately. Then take your next dose at the usual time the following day.
- More than 12 hours late: Skip the missed dose entirely. Take your next dose at the regular time the following day.
- If you vomit: Do not take a replacement dose. Take the next dose at the usual time.
Never take a double dose to make up for a forgotten one.
Overdose
If you take more Jaypirca than prescribed, contact your doctor immediately or go to the nearest hospital emergency department for advice. Bring the tablets and this information with you so that the medical team knows what you have taken. Medical treatment may be necessary depending on the amount of the overdose and any symptoms that develop.
What Are the Side Effects of Jaypirca?
Like all medicines, Jaypirca can cause side effects, although not everyone will experience them. Some side effects can be serious and require immediate medical attention, while others are milder and may improve over time as your body adjusts to the medication. Your healthcare team will monitor you regularly during treatment to detect and manage any side effects as early as possible.
Itchy raised rash (hives), difficulty breathing, or swelling of the face, lips, tongue, or throat — these may be signs of a serious allergic reaction to the medication.
Fever, chills, weakness, confusion, cough, cold or flu-like symptoms, shortness of breath, pain or burning when urinating (signs of infection); unusual bleeding or bruising, pink or brown urine, black stools, bleeding gums, or blood in vomit (signs of bleeding); or irregular heartbeat, weak or uneven pulse, fainting, shortness of breath, or chest discomfort (signs of heart rhythm disturbance).
The following side effects have been reported in clinical studies and post-marketing experience with Jaypirca, organized by how frequently they occur:
Very Common
- Fatigue (tiredness, weakness)
- Infections (including pneumonia, upper respiratory infections, urinary tract infections)
- Neutropenia (low white blood cell count)
- Diarrhea (more frequent or loose stools)
- Bruising and contusion (bleeding into the skin)
- Nausea (feeling sick)
- Anemia (low red blood cell count, may cause tiredness and pale skin)
- Arthralgia (joint pain)
- Thrombocytopenia (low platelet count)
- Skin rash
- Abdominal pain (stomach pain)
- Peripheral edema (swollen hands, ankles, or feet)
- Headache
Common
- Bleeding events (including nosebleeds, hematoma, conjunctival hemorrhage)
- Cardiac arrhythmias (irregular heartbeat, including atrial fibrillation)
- Lymphocytosis (higher than normal lymphocyte count in the blood)
- Petechiae (small pinpoint bleeding spots in the skin)
Frequency Not Known
- Elevated liver enzyme levels
- Tumor lysis syndrome (rapid breakdown of cancer cells)
Your doctor will regularly check your blood counts during treatment with Jaypirca to monitor for low neutrophils, low platelets, and anemia. If blood counts drop to dangerously low levels, your doctor may temporarily pause treatment or reduce the dose. If you notice any new or worsening symptoms during treatment, report them to your healthcare team promptly, even if they seem minor. Early detection and management of side effects can help you stay on treatment longer and with better quality of life.
It is important to report suspected side effects after a medication has been approved. This allows continuous monitoring of the medication's benefit-risk balance. Healthcare professionals and patients can report suspected adverse reactions to their national regulatory authority (e.g., FDA MedWatch in the United States, Yellow Card Scheme in the UK, or the EMA in the European Union).
How Should You Store Jaypirca?
Proper storage of Jaypirca is important to ensure the medication remains effective and safe throughout its shelf life. The following storage guidelines should be observed:
- Temperature: No special storage conditions are required. Store at room temperature.
- Keep out of reach: Store this medication out of the sight and reach of children at all times.
- Expiration date: Do not use Jaypirca after the expiration date (EXP) printed on the carton and blister pack. The expiration date refers to the last day of the stated month.
- Original packaging: Keep the tablets in their original blister packaging until you are ready to take them.
- Disposal: Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.
If you notice any changes in the appearance of the tablets (such as discoloration, crumbling, or an unusual odor), do not take them and consult your pharmacist for a replacement.
What Does Jaypirca Contain?
Each Jaypirca tablet contains pirtobrutinib as its active pharmaceutical ingredient. The following information describes the composition and appearance of each available tablet strength:
| Strength | Appearance | Imprint | Pack Sizes |
|---|---|---|---|
| 50 mg | Blue, rounded triangular film-coated tablet | "Lilly 50" on one side, "6902" on the other | 28, 30, or 84 tablets |
| 100 mg | Blue, round film-coated tablet | "Lilly 100" on one side, "7026" on the other | 28, 30, 56, 60, 84, or 168 tablets |
Not all pack sizes may be marketed in every country. The tablets are supplied in blister packs.
Inactive Ingredients (Excipients)
In addition to the active ingredient, Jaypirca tablets contain the following inactive components:
- Tablet core: Hypromellose acetate succinate, microcrystalline cellulose, lactose monohydrate (see lactose warning above), croscarmellose sodium (see sodium information above), magnesium stearate, colloidal hydrated silicon dioxide.
- Film coating: Hypromellose, titanium dioxide, triacetin, indigo carmine (E132).
Jaypirca is manufactured by Lilly S.A. in Alcobendas, Madrid, Spain, and the marketing authorization holder is Eli Lilly Nederland B.V. in Utrecht, the Netherlands. The product has received conditional marketing authorization in the European Union, meaning that additional data on the medicine is expected and will be reviewed annually by the European Medicines Agency (EMA).
Frequently Asked Questions About Jaypirca
Jaypirca (pirtobrutinib) is used to treat two types of blood cancer in adults: mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). It is specifically indicated for patients who have previously been treated with another Bruton's tyrosine kinase (BTK) inhibitor and whose cancer has come back (relapsed) or has not responded to that treatment (refractory). Jaypirca is taken as a single-agent oral therapy (monotherapy).
Jaypirca is a non-covalent (reversible) BTK inhibitor, whereas ibrutinib, acalabrutinib, and zanubrutinib are all covalent (irreversible) BTK inhibitors. Covalent BTK inhibitors bind permanently to a specific site (C481) on the BTK enzyme. Over time, cancer cells can develop a mutation at this site (C481S) that prevents the drug from binding, leading to resistance and disease progression. Jaypirca binds to BTK through a different mechanism that does not depend on the C481 site, so it remains effective even against BTK with this resistance mutation.
The most common side effects (affecting more than 1 in 10 patients) include fatigue, infections (such as pneumonia, upper respiratory infections, urinary tract infections), low white blood cell count (neutropenia), diarrhea, bruising, nausea, low red blood cell count (anemia), joint pain, low platelet count (thrombocytopenia), skin rash, abdominal pain, swelling of the hands, ankles, or feet (edema), and headache. Your healthcare team will monitor you regularly with blood tests and physical examinations to detect and manage these effects.
The recommended dose is 200 mg taken orally once daily. This can be achieved with four 50 mg tablets or two 100 mg tablets. The tablets should be swallowed whole with water at approximately the same time each day and can be taken with or without food. Do not chew, crush, or split the tablets. If you miss a dose and it is less than 12 hours late, take it immediately; if more than 12 hours, skip the missed dose and resume at the next scheduled time.
No. Jaypirca should not be used during pregnancy as it may harm the developing baby. Women of childbearing potential must use effective contraception during treatment and for at least 5 weeks after the last dose. Men whose partners could become pregnant must use effective contraception during treatment and for at least 3 months after the last dose. Breastfeeding is also not recommended during treatment and for at least one week after the last dose, as it is not known whether pirtobrutinib passes into breast milk.
If less than 12 hours have passed since your usual dosing time, take the missed dose right away and then take the next dose at your regular time the next day. If more than 12 hours have passed, skip the missed dose and take your next dose at the usual time the following day. Do not take a double dose. If you vomit after taking Jaypirca, do not take a replacement dose — simply take the next dose at the scheduled time.
References
- Mato AR, Shah NN, Jurczak W, et al. Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study. The Lancet. 2023;401(10374):411–422. doi:10.1016/S0140-6736(22)02399-9
- Mato AR, Woyach JA, Brown JR, et al. Pirtobrutinib after a covalent BTK inhibitor in CLL and other B-cell malignancies. N Engl J Med. 2023;389(1):33–44. doi:10.1056/NEJMoa2300696
- European Medicines Agency (EMA). Jaypirca (pirtobrutinib) — Summary of Product Characteristics. Available at: EMA — Jaypirca.
- U.S. Food and Drug Administration (FDA). Jaypirca (pirtobrutinib) — Prescribing Information. Available at: FDA — Jaypirca Label.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas. Version 2.2025. Available at: NCCN Guidelines.
- Dreyling M, Campo E, Hermine O, et al. Newly diagnosed and relapsed mantle cell lymphoma: ESMO Clinical Practice Guidelines. Ann Oncol. 2024;35(1):14–28.
- Eichhorst B, Robak T, Montserrat E, et al. Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines. Ann Oncol. 2024;35(2):133–147.
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List. Geneva: World Health Organization; 2023.
- Wang ML, Blum KA, Martin P, et al. Long-term follow-up of MCL patients treated with single-agent ibrutinib: updated safety and efficacy results. Blood. 2015;126(6):739–745.
- Woyach JA, Ruppert AS, Guinn D, et al. BTKC481S-mediated resistance to ibrutinib in chronic lymphocytic leukemia. J Clin Oncol. 2017;35(13):1437–1443.
Medical Editorial Team
This article has been medically reviewed and fact-checked by our team of specialist physicians and pharmacologists. All content follows the iMedic Editorial Standards and is based on peer-reviewed research and international clinical guidelines.
Hematology-Oncology Specialist
Board-certified specialist in hematology and medical oncology with clinical expertise in B-cell lymphoma, CLL treatment, and targeted cancer therapies including BTK inhibitors.
Clinical Pharmacology Specialist
Licensed pharmacologist specializing in oncology drug interactions, pharmacokinetics, and evidence-based medication safety review.
Medical Content Editor
Experienced medical writer and editor ensuring clinical accuracy, readability, and compliance with health literacy standards.
Quality Assurance Reviewer
Independent reviewer verifying medical claims against source literature, checking evidence grading (GRADE framework), and ensuring guideline concordance.
All medical content is reviewed according to the GRADE evidence framework. Sources include EMA, FDA, NCCN, ESMO, and WHO guidelines, as well as peer-reviewed publications in The Lancet, New England Journal of Medicine, Blood, and Journal of Clinical Oncology. No pharmaceutical company sponsorship or advertising influences our editorial decisions.