'Ensuring safety during long-term treatment is increasingly important as the recent expansion in treatment options may lead to longer survival for patients with CLL. As a result, there is a growing unmet medical need for treatments that control disease and have an acceptable safety profile,' said Chugai's President and CEO, Dr.
'We are very pleased that Gazyva was applied for marketing approval for a new indication in CLL,' said
The filing is based on the results including Phase III ELEVATE-TN study (ACE-CL-007) conducted by
About ELEVATE-TN study
ELEVATE-TN (ACE-CL-007, NCT02475681) study is a randomized, multicenter, open-label Phase III trial evaluating the safety and efficacy of acalabrutinib in combination with obinutuzumab or alone versus chlorambucil (unapproved) in combination with obinutuzumab in previously untreated patients with CLL. In the study, patients are randomized 1:1:1 to following groups; Chlorambucil plus obinutuzumab, Acalabrutinib plus obinutuzumab, Acalabrutinib monotherapy
The primary endpoint is IRC-assessed progression-free survival (PFS) with acalabrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab. Secondary endpoint is IRC-assessed PFS with acalabrutinib monotherapy versus chlorambucil plus obinutuzumab. Other secondary endpoints are objective response rate, time to next treatment and overall survival etc 1).
About Gazyva (obinutuzumab)
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
About chronic lymphocytic leukemia (CLL)
Chronic lymphocytic leukemia (CLL) a rare type of lymphoma accounting for less than one case in 100,000 population annually 2). 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 platelets. This could result in anemia, infection, and bleeding 3). B-cell receptor signaling through BTK is one of the essential growth pathways for CLL.
Trademarks used or mentioned in this release are protected by law.
Contact:
Media
Tel: +81-(0)3-3273-0881
E-mail: pr@chugai-pharm.co.jp
Investor
Tel: +81-(0)3-3273-0554
E-mail: ir@chugai-pharm.co.jp
(C) 2022 Electronic News Publishing, source