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NEWS 2025
September 19, 2025
Pharmaceuticals
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Lilly's antineoplastic agent Jaypirca® 50 mg and 100 mg tablets obtains additional approval as a treatment for relapsed or refractory chronic lymphocytic leukemia 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: Simone Thomsen) have announced that Eli Lilly Japan obtained additional approval for its antineoplastic agent Jaypirca® 50 mg and 100 mg tablets (generic name: pirtobrutinib; hereinafter "Jaypirca") as a treatment for patients with relapsed or refractory chronic lymphocytic leukemia (including small lymphocytic lymphoma) who are resistant or intolerant to other BTK inhibitors on September 19, 2025.
Jaypirca is a Bruton tyrosine kinase (BTK) inhibitor that binds reversibly and noncovalently to BTK. BTK is expressed in many types of B-cell lymphomas, including chronic lymphocytic lymphoma (CLL) and mantle cell lymphoma (MCL), and has been used as a therapeutic target for these diseases.
This sNDA (supplemental New Drug Application) approval is based on the efficacy and safety data obtained in a global phase III randomized study called BRUIN-CLL-321. The study compared pirtobrutinib monotherapy versus the investigator’s choice of chemotherapy in patients with relapsed or refractory CLL or small lymphocytic lymphoma (SLL) who were resistant or intolerant to covalent BTK inhibitors. In this study, pirtobrutinib met the primary endpoint of progression-free survival (PFS): Median PFS was significantly longer in the pirtobrutinib than in the chemotherapy group.
In Japan, based on the alliance agreement concluded in March 2024, Eli Lilly Japan is responsible for supply of Jaypirca, while Nippon Shinyaku is responsible for distribution and sales, as well as information provision activities.
About the product
| Brand name | Jaypirca® 50 mg Tablets and Jaypirca® 100 mg Tablets |
| Generic name | pirtobrutinib |
| Indications | 1）Patients with relapsed or refractory mantle cell lymphoma who are resistant or intolerant to other BTK inhibitors 2）Patients with relapsed or refractory chronic lymphocytic leukemia (including small lymphocytic lymphoma) who are resistant or intolerant to other BTK inhibitors. |
| Dosage & Administration | In adult patients, the recommended dosage is pirtobrutinib 200 mg orally once daily. Reduce the dose accordingly based on the patient's condition. |
| Date of marketing drug approval | June 24, 2024 |
| Date of NHI price listing | August 15, 2024 |
| Launch date | August 21, 2024 |
| NHI price | Jaypirca® 50 mg Tablets 10,201.00 yen per one tablet Jaypirca® 100 mg Tablets 19,465.80 yen per one tablet |
| Manufacturer | Eli Lilly Japan K.K. |
| Distributor | Nippon Shinyaku Co., Ltd. |
Product images
Jaypirca® 50 mg Tablets Jaypirca® 100 mg Tablets
About the Global Phase III study (BRUIN-CLL-321)
The BRUIN-CLL-321 study enrolled a total of 238 patients (including 3 Japanese patients) with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who were resistant or intolerant to covalent BTK inhibitors (e.g., ibrutinib, acalabrutinib, and zanubrutinib), who were randomized to receive pirtobrutinib 200 mg orally once daily ("the pirtobrutinib gorup") or investigator's choice of idelalisib [not approved in Japan] plus rituximab (IdelaR)1) or bendamustine plus rituximab (BR)2) ("the chemotherapy group). The primary endpoint was progression-free survival (PFS) assessed by an independent review committee (IRC). As the following table shows, PFS was significantly longer in the pirtobrutinib group than in the chemotherapy group.3)
Table: Results of the global phase III randomized BRUIN-CLL-321 study
a) Calculated using a stratified Cox proportional hazards model.
b) Stratified log-rank test; The level of significance was set at 0.05 for both sides.
Among the 116 patients (including 3 Japanese patients) who received pirtobrutinib and were included in the safety analysis set, 61 patients (52.6%) experienced adverse drug reactions, such as neutropenia (11.2%), anemia (7.8%), diarrhea (6.9%), fatigue (5.2%), decreased neutrophil count (5.2%), and headache (5.2%).3)
1) Patients received idelalisib (not approved in Japan) 150 mg orally twice daily and rituximab (genetical recombination) 375 mg/m2 IV once on Day 1 of the first 28-day cycle, 500 mg/m2 IV 4 times every other week, and then 500 mg/m2 IV 3 times every four weeks.
2) Patients received bendamustine 70 mg/m2 IV once on Days 1 and 2 of six 28-day cycles, rituximab (genetical recombination) 375 mg/m2 IV once on Day 1 of the first 28-day cycle, 500 mg/m2 IV 4 times every other week, and then 500 mg/m2 IV 3 times every four weeks.
3) Package insert for Jaypirca
About Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)
CLL and SLL are forms of slow-growing blood tumors that develop from white blood cells known as lymphocytes.i,ii CLL and SLL are rare diseases in Japan where about 7,000 and 4,000 people are suffering from these diseases. SLL is identical to CLL from a pathologic and immunophenotypic standpoint, with the main difference between them being the location of the cancer cells.i In CLL, the cancer cells are present in the blood, and in SLL, the cancer cells are found in the lymph nodes. i
i. Mukkamalla SKR, Taneja A, Malipeddi D, et al. Chronic Lymphocytic Leukemia. [Updated 2023 Feb 18]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan. Available from: https://www.ncbi.nlm.nih.gov/books/NBK470433/
ii. The Leukemia and Lymphoma Society. NHL Subtypes. Access here: https://bloodcancerunited.org/blood-cancer/lymphoma/non-hodgkin-lymphoma-nhl
Accessed on October 25, 2023.
iii. Official Statistics of Japan. Patient survey in FY2023.
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 to patients and families suffering from illness. Please visit our website (https://www.nippon-shinyaku.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 have been 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.
Contact
Corporate Communications Dept., Nippon Shinyaku Co., Ltd.
e_mail_kouhou@po.nippon-shinyaku.co.jp