ABSTRACT Expedited pathways in the United States (U.S.), European Union (EU), and Japan (JP) enable earlier access to innovative therapies for rare and serious diseases. In 2025, Japan explicitly introduced revocation provisions to its Conditional Early Approval (CEA).
Takahiro Handa +3 more
wiley +1 more source
ABSTRACT Introduction Novel targeted agents have transformed the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), including continuous BTK inhibitor (BTKi) therapy and time‐limited regimens such as venetoclax‐obinutuzumab (Ven‐O) and ibrutinib‐venetoclax (I + V).
Rebecca Tidswell +7 more
wiley +1 more source
Acalabrutinib in Chronic Lymphocytic Leukemia: Pharmacology and Emerging Clinical Perspectives
ABSTRACT Acalabrutinib, a second‐generation Bruton's tyrosine kinase inhibitor (BTKi), is characterized by enhanced specificity and selectivity for BTK with minimal off‐target effects, offering a significant evolution in the treatment of chronic lymphocytic leukemia (CLL). Its mechanism of action, a covalent binding to Cys481 within the BTK active site,
Gianluca Gaidano, Romano Danesi
wiley +1 more source
Function of Bruton's tyrosine kinase during B cell development is partially independent of its catalytic activity [PDF]
The Tec family member Bruton's tyrosine kinase (Btk) is a cytoplasmic protein tyrosine kinase that transduces signals from the pre-B and B cell receptor (BCR).
Middendorp, S. +9 more
core
Bruton's Tyrosine Kinase Inhibitors in Multiple Sclerosis. [PDF]
Lambe J, Fox RJ.
europepmc +1 more source
Visualization of a Bruton's Tyrosine Kinase Inhibitor Using Fluorescence and Raman Microscopy. [PDF]
Merchant AS +3 more
europepmc +1 more source
Evaluation of Cardiotoxicity in Lymphoproliferative Patients Treated With Anthracycline and Bruton's Tyrosine Kinase Inhibitor-Based Regimens. [PDF]
Bonsu A.
europepmc +1 more source
Membrane-dependent assembly of Bruton's tyrosine kinase mediated by the Proline-rich region and SH3 domain. [PDF]
Fenton AD, Chung JK.
europepmc +1 more source
Economic Evaluation of Bruton's Tyrosine Kinase Inhibitors for Chronic Lymphocytic Leukaemia in South Africa. [PDF]
Woudberg R, Sinanovic E.
europepmc +1 more source

