- FDA approved Jaypirca for previously untreated CLL/SLL without 17p deletion.
- Approval based on BRUIN CLL-313 Phase 3 trial.
- pirtobrutinib showed HR=0.20 for PFS vs bendamustine plus rituximab.
- Median PFS not reached for pirtobrutinib vs 33.5 months for BR.
- ORR 94% for pirtobrutinib vs 81% for BR.
- Serious adverse reactions occurred in 28% of patients on Jaypirca.
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