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Tirabrutinib

Primary central nervous system lymphoma

Regulatory submission
NDA submitted December 2025
Last updated
72 sources

Product information and disease descriptionPlace of product in therapyApproaches to treatment

Place in treatment, anticipated use, and care setting

1 evidence topic · 3 sources

Summary

Tirabrutinib's established marketed use in the cited Japanese sources is relapsed or refractory PCNSL. The usual adult Japanese dosage is 480 mg orally once daily under fasting conditions. The EHA-ESMO guideline identifies tirabrutinib as an option in relapsed or refractory disease and recommends specialist multidisciplinary care. PROSPECT Part B investigates its addition to MTR or R-MPV in newly diagnosed PCNSL; that investigational use should not be treated as an approved first-line indication.