Conclusions
1 evidence topic · 5 sources
Summary
Tirabrutinib has Japanese approval and is identified in the EHA-ESMO guideline as an option for relapsed or refractory PCNSL. The U.S. application was accepted for review under the accelerated approval pathway, with a stated PDUFA date of December 18, 2026; this is not an approval. Japanese safety precautions specify permanent discontinuation for Stevens-Johnson syndrome or toxic epidermal necrolysis. The retained sources give different Taiwan approval dates: the company states February 2022, whereas the regulator's assessment report records October 29, 2021.