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EMA's CHMP gives positive opinion for Jaypirca to treat chronic lymphocytic leukemia across all therapy lines.

Market News
26 Jun 2026
PRNewsWire
View Source
Bullish
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The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jaypirca (pirtobrutinib), a non-covalent BTK inhibitor, for treating adults with chronic lymphocytic leukemia (CLL) across all lines of therapy. This recommendation follows strong results from Phase 3 BRUIN CLL-313 and BRUIN CLL-314 trials, which showed Jaypirca's efficacy and tolerability in both treatment-naïve and previously treated patients. The application now moves to the European Commission for final approval, expected within one to two months. Approval would expand treatment options for CLL patients in the European Union, and Lilly is also seeking FDA approval in the U.S. later in 2026.

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