Press Release
Nippon Shinyaku Co., Ltd.
Eli Lilly Japan K.K.

June 24, 2024

Japan’s PMDA approves Antineoplastic Agent"Jaypirca® 50 mg and 100 mg tablets"for Patients with Relapsed or Refractory Mantle Cell Lymphoma
Who are Resistant or Intolerant to Other BTK Inhibitors

Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; Headquarters: Kyoto; President: Toru Nakai) and Eli Lilly
Japan K.K. (Eli Lilly Japan; Headquarters: Kobe; President and Representative Director: SimoneThomsen) announced today, June 24, 2024, that Eli Lilly Japan has received marketing authorization inJapan for the antineoplastic agent "Jaypirca® 50 mg and 100 mg tablets" (generic name: pirtobrutinib;
hereinafter referred to as "Jaypirca") for the treatment of "patients with relapsed or refractory mantle cell
lymphoma who are resistant or intolerant to other BTK inhibitors."
Jaypirca is a Bruton tyrosine kinase (BTK) inhibitor that binds reversibly and noncovalently to BTK. BTK
is recognized as a target for a variety of B-cell lymphomas, including mantle cell lymphoma (MCL), andleukemia, including chronic lymphocytic leukemia (CLL).1,2
Approval of Jaypirca is based on the efficacy and safety results of Study BRUIN-18001, a global Phase
1/2 study. In this study, the efficacy and safety of Jaypirca were evaluated in patients with relapsed orrefractory MCL who were resistant or intolerant to other covalent BTK inhibitors. The centrally assessed
overall response rate, the primary endpoint, was 56.9% (95% confidence interval: 44.0, 69.2). The mostcommon adverse drug reactions were fatigue, diarrhea, bruising, dyspnea, muscle pain, platelet countdecreased, anemia, and cough.
Based on the alliance agreement concluded in March 2024, Eli Lilly Japan will be responsible for supplyof Jaypirca in Japan, while Nippon Shinyaku will be responsible for distribution and sales, as well as
information provision activities.
Summary of Product Information
Brand name:
Jaypirca® 50 mg tablet, Jaypirca® 100 mg tablet
Generic name:Indications:
Dosage and administration:

Date of marketing approval:

Pirtobrutinib
Patients with relapsed or refractory mantle cell lymphoma who areresistant or intolerant to other BTK inhibitors
In adult patients, the recommended dosage is pirtobrutinib
200 mg orally once daily. Reduce the dose accordingly based on
the patient's condition.
June 24, 2024

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About the Global Phase 1/2 Study (BRUIN-18001)※
In the BRUIN-18001 trial, patients with relapsed or refractory mantle cell lymphoma who were resistantor intolerant to other covalent BTK inhibitors were randomized to receive Jaypirca 200 mg1 orally oncedaily. Among 65 patients in the primary efficacy analysis population2, the centrally assessed overall
response rate, the primary endpoint, was 56.9% (95% confidence interval: 44.0, 69.2). The overall
response rate in 8 Japanese patients3 was 50.0% (95% confidence interval: 15.7, 84.3). Among 15
patients with blastoid mantle cell lymphoma previously treated with other covalent BTK inhibitors, theoverall response rate was 46.7% (95% confidence interval: 21.3, 73.4).*
Adverse drug reactions were reported in 104 (63.4%) of 164 subjects1, 4 in the safety analysis population.
The most common adverse drug reactions were fatigue (22.0%), diarrhea (12.2%), bruising (9.8%),
dyspnea (9.1%), muscle pain (8.5%), platelet count decreased (6.7%), anemia (6.1%), and cough (6.1%).
Note 1: Included patients whose starting dose of Jaypirca was not 200 mg.
Note 2: Among patients with non-blastoid mantle cell lymphoma previously treated with other covalent BTK inhibitors, up
to 65 patients in the order of initiation of treatment were included in the primary efficacy analysis population.
Note 3: Among Japanese patients with non-blastoid mantle cell lymphoma previously treated with other covalent BTK
inhibitors, up to 8 patients in the order of initiation of treatment were included in the primary efficacy analysis population.
Note 4: All patients with mantle cell lymphoma who received at least one dose of Jaypirca alone.
* The analysis was performed at the request of regulatory authorities after filing the application for marketing approval.
※Based on the package insert for Jaypirca.

About Mantle Cell Lymphoma
MCL is a rare blood cancer and a form of non-Hodgkin lymphoma. MCL arises in B lymphocytes, a typeof white blood cell. MCL frequently begins in B cells located in the mantle zone of the outer edge of lymph
nodes. As the cancer progresses, it can spread to bone marrow, the spleen, the liver, or the digestive
tract.3 Annually, about one in 200,000 people worldwide develop MCL3.
About Nippon Shinyaku
Based on Nippon Shinyaku’s business philosophy, “Helping people lead healthier, happier lives,” we aim
to be an organization trusted by the community through creating unique medicines that will bring hope topatients and families suffering from illness. Please visit our website (https://www.nipponshinyaku.co.jp/english/) for products or detailed information.
About Eli Lilly Japan
Eli Lilly Japan is the Japanese subsidiary of Eli Lilly and Company based in the United States. We havebeen developing and supplying world-class, innovative medicines by uniting caring with discovery for 50
years to help patients in Japan achieve healthier and more fulfilling lives. We currently contribute to Japanese medicine in multiple areas, including cancer, diabetes, Alzheimer's disease and other central nervous system diseases, as well as autoimmune diseases, etc. For more details, please visit our website.
https://www.lilly.com/jp###

1. Hanel W, Epperla N. Emerging therapies in mantle cell lymphoma. J Hematol Oncol. 2020;13(1):79.
Published 2020 Jun 17. doi:10.1186/s13045-020-00914-1
2. Gu D, Tang H, Wu J, Li J, Miao Y. Targeting Bruton tyrosine kinase using non-covalent inhibitors in B
cell malignancies. J Hematol Oncol. 2021;14(1):40. Published 2021 Mar 6. doi:10.1186/s13045-02101049-7
3. National Organization for Rare Disorders. Mantle cell lymphoma. Accessed 26 October 2022.
https://rarediseases.org/rare-diseases/mantle-cell-lymphoma
Contact
Corporate Communications Dept., Nippon Shinyaku Co., Ltd.
FAX: +81-75-321-9128

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