Brand Name

Jaypirca

Generic Name
Pirtobrutinib
View Brand Information
FDA approval date: January 27, 2023
Classification: Kinase Inhibitor
Form: Tablet

What is Jaypirca (Pirtobrutinib)?

For many people living with certain blood cancers, treatment can feel like a constant balancing act, finding a therapy that controls the disease without overwhelming side effects. Jaypirca (pirtobrutinib) offers new hope for patients whose cancer has become resistant to earlier treatments.

Jaypirca is an oral, targeted therapy developed by Eli Lilly for adults with specific types of B-cell malignancies, such as mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). It belongs to a newer class of medications called Bruton’s tyrosine kinase (BTK) inhibitors, which work by interfering with signals that help cancer cells grow and survive.

Approved by the U.S. Food and Drug Administration (FDA) in 2023, Jaypirca represents a next-generation option for patients who no longer respond to older BTK inhibitors like ibrutinib or acalabrutinib, helping extend both treatment options and quality of life (FDA, 2023).

What does Jaypirca do?

Jaypirca is used to treat relapsed or refractory mantle cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in adults who have previously received at least two lines of therapy, including another BTK inhibitor.

By targeting cancer cells that rely on abnormal BTK signaling, Jaypirca helps slow or stop tumor growth and may reduce symptoms such as swollen lymph nodes, fatigue, or night sweats.

In clinical studies, many patients experienced durable responses, meaning their cancer remained under control for a significant period, even after prior treatments had stopped working (Mato et al., 2023).

For many individuals, this can translate to improved energy, fewer disease-related complications, and a more stable daily life.

How does Jaypirca work?

Jaypirca is a highly selective, reversible inhibitor of Bruton’s tyrosine kinase (BTK), a protein that plays a key role in the signaling pathways of B-cells, which are part of the immune system.

In many B-cell cancers, BTK becomes overactive, sending continuous “grow and survive” signals that drive cancer progression.

Unlike earlier BTK inhibitors that form irreversible bonds with the BTK enzyme, Jaypirca binds reversibly, allowing it to remain effective even in cases where mutations have made the cancer resistant to older drugs. This design gives Jaypirca a unique advantage for patients whose cancers have developed resistance mutations such as C481S (FDA, 2023).

Clinically, this mechanism matters because it helps restore disease control while minimizing damage to healthy cells, leading to fewer off-target effects and often better tolerability.

Jaypirca side effects

Like all cancer treatments, Jaypirca can cause side effects, although not everyone experiences them. Understanding what to expect can help patients manage therapy more confidently.

Common side effects:

  • Fatigue
  • Diarrhea or nausea
  • Muscle or joint pain
  • Bruising or bleeding
  • Rash

Less common but potentially serious side effects:

  • Low blood counts (cytopenias), which can lead to fatigue, easy bruising, or increased infection risk
  • Infections,most particularly respiratory infections
  • Heart rhythm problems (atrial fibrillation) that present as palpitations, dizziness, or shortness of breath
  • Bleeding events, including rare cases of serious internal bleeding

Patients should seek immediate medical attention if they experience severe bleeding, chest pain, signs of infection (fever, chills), or allergic reactions such as swelling or difficulty breathing.

Jaypirca may not be appropriate for people with active infections, severe liver disease, or significant bleeding disorders. Your doctor will assess your health history and medications to minimize risks and drug interactions (MedlinePlus, 2024).

Overall, Jaypirca’s side-effect profile is generally considered manageable, and many patients can remain on treatment long-term with regular monitoring and supportive care.

Jaypirca dosage

Jaypirca is taken by mouth, once daily, as prescribed by your oncologist. It can be taken with or without food. Because dosing may depend on other medications or side effects, patients should never adjust their dose or stop treatment without medical guidance.

Ongoing monitoring is an essential part of safe therapy. Your doctor will likely perform:

  • Blood tests to check white and red blood cell counts and platelet levels
  • Liver function tests to ensure safe metabolism
  • Cardiac monitoring if there’s a history of heart rhythm issues
  • Periodic imaging or clinical assessments to track cancer response

These evaluations help ensure Jaypirca continues to work effectively and allow early detection of any adverse effects.

For older adults or those with organ impairment, clinicians may consider dose adjustments or closer follow-up to maintain safety (NIH, 2024).

Does Jaypirca have a generic version?

As of 2025, no generic version of Jaypirca (pirtobrutinib) is available. It remains marketed under its brand name by Eli Lilly, and no FDA-approved generics exist domestically or internationally (FDA Orange Book, 2025). However, international versions may exist in other markets.

When generics eventually become available, they will contain the same active ingredient and must demonstrate equivalent safety and effectiveness to the brand-name product. Patients can be assured that approved generics meet the same rigorous standards as original medications.

For now, insurance coverage and patient-assistance programs through Lilly Cares or oncology support foundations may help offset treatment costs for eligible patients.

Conclusion

Jaypirca (pirtobrutinib) represents an important advancement in targeted cancer therapy, giving new treatment options to patients with mantle cell lymphoma or CLL who have exhausted prior BTK inhibitors. By blocking abnormal cell-growth signals in a more flexible, reversible way, it helps re-establish disease control with a manageable safety profile.

While individual experiences vary, many patients benefit from prolonged remission periods, improved daily functioning, and renewed optimism about long-term management.

When used under expert supervision, Jaypirca can be a safe and effective tool in maintaining remission and improving quality of life for people facing difficult-to-treat blood cancers.

References

  1. U.S. Food and Drug Administration (FDA). (2023). Jaypirca (pirtobrutinib) prescribing information. https://www.fda.gov/
  2. Mato, A. R., et al. (2023). Pirtobrutinib in relapsed or refractory B-cell malignancies. New England Journal of Medicine. https://www.nejm.org/
  3. MedlinePlus. (2024). Pirtobrutinib: Drug information. U.S. National Library of Medicine. https://medlineplus.gov/
  4. National Institutes of Health (NIH). (2024). BTK inhibitors in hematologic malignancy. https://www.nih.gov/

Related Clinical Trials

Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-18001 With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma

Summary: Study J2N-MC-JZ01 (JZ01) is an individual-study appendix (ISA) under master protocol J2N-MC-JZNY, and represents participants from the completed originator study, clinical study LOXO-BTK-18001/J2N-OX-JZNA. Participants in the originator study will have the opportunity to continue their assigned study intervention or continue their follow-up visits by transitioning to this study. This study will ev...

A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor

Summary: The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants ...

A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib

Summary: The master protocol study J2N-MC-JZNY provides a framework to enable the evaluation of the long-term safety and efficacy of pirtobrutinib after completion of clinical studies evaluating pirtobrutinib. The clinical studies that will feed into this master protocol are referred to as originator studies. The master protocol will govern individual study-specific appendices (ISAs) that will represent pa...

Brand Information

JAYPIRCA (pirtobrutinib)
1DOSAGE FORMS AND STRENGTHS
Tablets:
Each 50 mg tablet is blue, arc-triangle shaped, film-coated, and debossed with “Lilly 50” on one side and “6902” on the other side.
Each 100 mg tablet is blue, round, film-coated, and debossed with “Lilly 100” on one side and “7026” on the other side.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Infections
  • Hemorrhage
  • Cytopenias
  • Atrial Fibrillation and Atrial Flutter
  • Second Primary Malignancies
  • Hepatotoxicity, including DILI
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared to rates in the clinical trials of another drug and may not reflect the rates observed in the general patient population.
The data in the WARNINGS AND PRECAUTIONS reflect exposure to JAYPIRCA as a single-agent, administered at 200 mg once daily in 593 patients with hematologic malignancies in the BRUIN study. Among these 593 patients, the median duration of exposure was 10 months, 62% were exposed for at least 6 months and 45% were exposed for at least one year.
In this pooled safety population, the most common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased neutrophil count (46%), decreased hemoglobin (39%), fatigue (32%), decreased lymphocyte count (31%), musculoskeletal pain (30%), decreased platelet count (29%), diarrhea (24%), COVID-19 (22%), bruising (21%), and cough (20%).
4DESCRIPTION
Pirtobrutinib is a kinase inhibitor. It is an orally available, small molecule ATP-competitive inhibitor of BTK. The active pharmaceutical ingredient is pirtobrutinib with the molecular formula C
Chemical Structure
Pirtobrutinib is a white to practically white to yellow to brown solid. The aqueous solubility of pirtobrutinib is considered practically insoluble, or insoluble, across the pH 1 to pH 7 range.
Pirtobrutinib tablets are supplied as 50 mg or 100 mg film-coated, debossed tablets for oral administration. Each tablet contains inactive ingredients of croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide. The tablet film coating material contains FD&C Blue #2, hypromellose, titanium dioxide and triacetin.
5HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
JAYPIRCA tablets are supplied as follows:
Storage and Handling
Store JAYPIRCA tablets at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) ([see USP Controlled Room Temperature]).
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Infections
Advise patients that JAYPIRCA can cause serious infections that may be fatal. Advise patients to report any signs or symptoms of infection (e.g., fever, chills, weakness)
Hemorrhage
Inform patients to report signs or symptoms of bleeding. Inform patients that JAYPIRCA may need to be interrupted for major surgeries
Cytopenias
Advise patients of the need for periodic monitoring of blood counts during treatment with JAYPIRCA
Cardiac Arrhythmias
Counsel patients to report any signs of palpitations, dizziness, fainting, chest discomfort, and shortness of breath
Second Primary Malignancies
Inform patients that other malignancies have been reported in patients who have been treated with JAYPIRCA, including skin cancer and other solid tumors. Advise patients to use sun protection and to have monitoring for development of other cancers
Hepatotoxicity, Including Drug-Induced Liver Injury
Inform patients that liver problems, including severe, life-threatening, or fatal hepatitis, drug-induced liver injury and abnormalities in liver tests, may develop during JAYPIRCA treatment. Advise patients to contact their healthcare provider immediately if they experience abdominal discomfort, dark urine, or jaundice
Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy
Advise females of reproductive potential to use effective contraception during treatment with JAYPIRCA and for one week after the last dose
Lactation
Advise women not to breastfeed during treatment with JAYPIRCA and for one week after the last dose
Administration
Inform patients to take JAYPIRCA orally once daily at approximately the same time each day with or without food and how to make up a missed dose. Advise patients to swallow tablets whole with water. Advise patients not to cut, crush, or chew tablets
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright © 2023, 2024, Eli Lilly and Company. All rights reserved.
JAY-0004-USPI-20240604