Phase 3 data from the LUNA 3 trial supports rilzabrutinib as a first-in-class oral Bruton tyrosine kinase (BTK) inhibitor for patients with previously treated immune thrombocytopenia (ITP). The study showed that rilzabrutinib led to rapid and durable platelet responses, reduced bleeding, improved quality of life, and decreased need for rescue therapy in patients with persistent or chronic ITP. Notably, the drug also improved fatigue, even in patients with no significant rise in platelet count. Rilzabrutinib received fast-track designation in 2020 and is currently under regulatory review with a target action date of August 2025. Adverse events were generally mild to moderate, with diarrhea being the most common side effect.
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Rilzabrutinib Shines in Phase 3 Trial of Tough-to-Treat ITP
