Shots:
- The US FDA has granted FTD to Birelentinib (DZD8586) for the treatment of adults with r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received ≥2L of therapy, incl. a BTK & a BCL-2 inhibitor
- Designation was based on pooled P-I/II data showing 84.2% ORR & DoR rate of 83.3% at 9mos. in heavily pretreated CLL/SLL pts, incl. those harboring various BTK mutations; data was presented at EHA 2024 & ASCO 2025
- Birelentinib is a non-covalent dual LYN/BTK inhibitor with full BBB penetration & high selectivity over other TEC kinases that blocks both BTK-dependent & independent BCR-signaling to inhibit B-cell non-Hodgkin lymphoma growth
Ref: Dizal | Image: Dizal | Press Release
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