Anti-Cancer Agent/Humanized Anti-CD20 Monoclonal Antibody Gazyva, Now Available for Use in Combination with Venetoclax for Previously Untreated Chronic Lymphocytic Leukemia

TOKYO, November 20, 2025 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) and Nippon Shinyaku Co., Ltd. (TOKYO: 4516) announced today that the electronic package insert for the anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva^® Intravenous Infusion 1000 mg [generic name: obinutuzumab (genetical recombination)] has been revised to allow combination therapy with the anti-cancer agent/BCL-2 inhibitor Venclexta^® Tablets 10 mg, 50 mg, and 100 mg [generic name: venetoclax] for previously untreated CD20-positive chronic lymphocytic leukemia (including small lymphocytic lymphoma).

This revision of the electronic package insert is based on the results of clinical studies evaluating the efficacy and safety of combination therapy with venetoclax and obinutuzumab for previously untreated chronic lymphocytic leukemia (including small lymphocytic lymphoma). These include a Japanese Phase II clinical study (M20-353) conducted by AbbVie GK and a global Phase III clinical study (CLL14/BO25323) conducted by Roche in cooperation with AbbVie Inc. and the German CLL Study Group from the University of Cologne.

Approval Information *Excerpt of relevant sections; underlined portions indicate changes

About the Japanese Phase II Clinical Study (M20-353)¹
M20-353 study is an uncontrolled, open-label Japanese Phase II clinical study to evaluate the efficacy and safety of venetoclax in combination with obinutuzumab and venetoclax in combination with ibrutinib in Japanese patients with treatment-naïve chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The primary endpoint was the rate of complete response (CR) and complete response with incomplete bone marrow recovery (CRi) as assessed by an Independent Review Committee (IRC).

About the Global Phase III Clinical Study (CLL14 Study, BO25323)²
CLL14 Study (BO25323) is a multicenter, randomized, open-label global Phase III clinical study comparing venetoclax in combination with obinutuzumab versus obinutuzumab in combination with chlorambucil (not approved in Japan) in patients with treatment-naïve CLL. The primary endpoint was progression-free survival (PFS) as assessed by investigators.

About Gazyva (obinutuzumab)³
Gazyva is a glycoengineered type II anti-CD20 monoclonal antibody designed to bind to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells. Gazyva is designed to attack and destroy targeted B cells both directly and together with the body’s immune system. Chugai and Nippon Shinyaku jointly develop and market the product in Japan.

About Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
In CLL, blood stem cells in the bone marrow become excessive abnormal lymphocytes and these abnormal cells have difficulty fighting infections. As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells, and platelets⁴. This could result in anemia, infection, and bleeding. SLL is the same type of cancer as CLL. When lymphocytes are not located in the peripheral blood or bone marrow, the disease is called SLL⁵. CLL/SLL is a rare type of lymphoma accounting for less than one case in 100,000 population annually in Japan⁶.

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Sources

1. Japan Registry of Clinical Trials (jRCT)
   [Internet; cited 2025 November]. Available from:
   https://jrct.mhlw.go.jp/en-latest-detail/jRCT2021210055
2. ClinicalTrials.gov. Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia [Internet; cited 2025 November]. Available from:
   https://www.clinicaltrials.gov/study/NCT02242942
3. Maloney DG：N Engl J Med. 2012;366:2008-16. (PMID：22621628) [Internet; cited 2025 November]. Available from:
   https://www.nejm.org/doi/full/10.1056/NEJMct1114348
4. National Cancer Institute. Chronic lymphocytic leukemia treatment (PDQ^®)-Patient version. [Internet; cited 2025 November]. Available from:
   https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq
5. Japanese Society of Hematology Practical Guidelines for Hematological Malignancies, 2024 Edition. [Internet; cited 2025 November]. Available from:
   https://www.jshem.or.jp/gui-hemali/1_5.html (in Japanese only)
6. Center for Cancer Control and Information Services, National Cancer Center. Chronic lymphocytic leukemia/small lymphocytic lymphoma
   [Internet; cited 2025 November]. Available from:
   https://ganjoho.jp/public/cancer/CLL/index.html (in Japanese only)