Lilly’s Jaypirca receives positive CHMP opinion for EU approval in adults with chronic lymphocytic leukaemia across all lines of therapy

The EMA’s Committee for Medicinal Products for Human Use has issued a positive opinion for Jaypirca, a non-covalent Bruton tyrosine kinase inhibitor, covering the treatment of adults with chronic lymphocytic leukaemia across all lines of therapy and irrespective of prior BTK inhibitor exposure. The application now passes to the European Commission for a final determination, with a decision anticipated within the next one to two months.

“Results from BRUIN CLL-313 and BRUIN CLL-314 provide compelling evidence that pirtobrutinib can make a meaningful difference for people living with CLL across multiple lines of therapy,” said Paolo Ghia, M.D., Professor of Medical Oncology at Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele in Milan, Italy. “The strong efficacy and tolerability demonstrated in these trials underscores the clinical value pirtobrutinib may offer patients. This positive opinion from the CHMP is an exciting and significant milestone, bringing us closer to a future where pirtobrutinib is an option for more people with CLL across the European Union.”

Evidence from both BRUIN CLL-313 and BRUIN CLL-314 was presented at the American Society of Hematology Annual Meeting and Exposition in December 2025 and subsequently published in The Journal of Clinical Oncology.

“Based on the strong results from the BRUIN CLL-313 and CLL-314 studies, we believe Jaypirca has the potential to serve as a meaningful new option for newly diagnosed patients and those who have not yet received a BTK inhibitor,” said Jacob Van Naarden, Executive Vice President and President of Lilly Oncology. “Thanks to the impact of contemporary CLL treatments, many patients may receive fewer lines of therapy over their lifetime, making treatment choices in earlier lines profoundly important. This CHMP opinion represents a step toward an important global approval for Jaypirca in this indication and reflects our ambition to make Jaypirca available to every CLL patient who may benefit, at any line of therapy. Today, we are on the brink of making that a reality across the European Union as we await the European Commission’s final decision.”

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Related Topics and Keywords

chronic lymphocytic leukaemia, Leukaemia, Lilly's Jaypirca