INDIANAPOLIS (dpa-AFX) - Eli Lilly and Co. (LLY, LLY.DE) on Friday announced that the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, issued a positive opinion recommending approval of Jaypirca or pirtobrutinib for the treatment of adults with chronic lymphocytic leukemia.
The recommendation covers patients across all lines of therapy, regardless of prior BTK inhibitor treatment.
The recommendation is based on results from the Phase 3 BRUIN CLL-313 and BRUIN CLL-314 trials.
If approved by the European Commission, Jaypirca's indication would be expanded for use in adults with CLL across all lines of therapy in the European Union.
A decision is expected within one to two months.
The company said it has also submitted the data to the U.S. Food and Drug Administration, with a regulatory decision expected in the second half of 2026.
In the pre-market trading, Eli Lilly and Co. is 0.19% lesser at $1,127.75 on the New York Stock Exchange.
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