Zanubrutinib is a Bruton’s tyrosine kinase inhibitor (BTKi) approved by the FDA in 2023 for the treatment of chronic lymphocytic leukaemia (CLL). Recognizing the emerging important role of BTKi as a therapeutic class in the treatment of CLL, the EML Committee advised that it would consider an application for zanubrutinib as therapeutic alternative for inclusion and recommended to MPP to explore it for licensing.