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DEC 18 2026
UPCOMING · 80 DAYS TO PDUFA

Deciphera Pharmaceuticals — tirabrutinib

for relapsed or refractory primary central nervous system lymphoma

NDA · Standard Review

Accepted FEB 18 2026.

About

Primary central nervous system lymphoma is an aggressive brain tumor that often occurs in people with severely weakened immune systems. Tirabrutinib is a drug designed to block a specific protein that helps these lymphoma cells survive and multiply. By inhibiting this protein, the drug could potentially slow the growth of this difficult-to-treat brain cancer.

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