The study is currently recruiting patients with R/R PCNSL in a global Phase 3 randomized trial called IGNITE, which will serve as a confirmatory study for this indication (ClinicalTrials.gov NCT07104032).
The FDA has set an action date of December 18, 2026, under the Prescription Drug User Fee Act (PDUFA).
To evaluate how well tirabrutinib stops disease progression and if there is a favorable safety profile compared with combination treatment of rituximab and temozolomide (R-TMZ) in adults with PCNSL whose disease has returned after response to treatment (relapsed) or has not improved with prior treatment/came back rapidly after initially responding (refractory).
Register today to receive the Zoom information to join this FREE online event.
Join this educational webinar about the IGNITE Phase 3 trial, which was designed to test if Trabrutinib works to treat primary central nervous system lymphoma (PCNSL), and to better understand the safety of the drug.
2026 KEYNOTE SPEAKER
Dr. Katherine Barnett Peters
Duke University School of Medicine Vice Chair, Education Professor of Neurosurgery Vice Chair for Education in the Department of Neurology Professor in Neurology Member of the Duke Cancer Institute
Tirabrutinib is an oral, once-daily, investigational medicine being studied in patients with PCNSL.
Tirabrutinib is being studied in clinical trials, but it is not approved for use in the United States or Europe.
Although not all side effects of tirabrutinib are known, the most common include:
Anemia
Fatigue
Neutropenia (low white blood cell count)
Itch/Rash
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