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AUG 17 2026
UPCOMING · 75 DAYS TO PDUFA

Deciphera Pharmaceuticals tirabrutinib

for relapsed or refractory primary central nervous system lymphoma

NDA

About

Primary central nervous system lymphoma (PCNSL) is an aggressive brain tumor that often strikes people with weakened immune systems, growing rapidly in the nervous system. Tirabrutinib blocks a protein called Bruton’s tyrosine kinase (BTK) that helps cancerous B-cells multiply and survive. By interrupting this growth signal, the drug may slow the lymphoma’s spread while being easier to tolerate than current combination therapies.

Pivotal trial

IGNITE Phase 3 recruiting NCT07104032

The purpose of this clinical trial is to evaluate efficacy and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) combination therapy in participants with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL).

Source: ClinicalTrials.gov

Also in development