Evicenter
P&T meetings

Tirabrutinib

Primary central nervous system lymphoma

Regulatory submission
NDA submitted December 2025
Last updated
72 sources

Clinical evidence

Severe central nervous system fungal infection case report

6 evidence topics · 1 source

Objective
Location and study date

No evidence found.

Study design
Eligibility criteria

Not applicable.

Treatment
Study outcomes
Rationale for using fungal infection as an observed safety outcome

Not applicable.

Statistical analysis description
Number of participants (Planned and analyzed)
Description of analysis sets

Not applicable.

Results
Participant disposition
Baseline characteristics
Efficacy results
Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results
Study limitations
Summary

The report describes one participant with Aspergillus encephalitis after tirabrutinib exposure and a subsequent fatal subcortical hemorrhage. A case report can identify a possible safety signal but cannot determine incidence or establish that tirabrutinib alone caused the infection or hemorrhage.