Eli Lilly and Company has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Jaypirca (pirtobrutinib) to treat chronic lymphocytic leukaemia (CLL) in adults.
This Jaypirca CHMP recommendation for CLL applies across all lines of therapy, regardless of previous Bruton tyrosine kinase (BTK) inhibitor treatment.
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Following this recommendation, the Jaypirca application moves to the European Commission (EC) for a decision, expected within the next one to two months.
Results from the BRUIN CLL-313 and BRUIN CLL-314 studies supported the application.
Lilly Oncology executive vice-president and president Jacob Van Naarden said: “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.
“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.”
Lilly has also submitted data from these studies to the US Food and Drug Administration (FDA), with a decision expected in the second half of 2026.
BRUIN CLL-313 is a global, open-label, Phase III study that involved 282 patients with CLL or small lymphocytic lymphoma without 17p deletions, randomised to receive either pirtobrutinib or chemoimmunotherapy.
BRUIN CLL-314 is a randomised, open-label, Phase III study assessing Jaypirca against Imbruvica (ibrutinib) in 662 patients who were treatment-naïve or BTK inhibitor-naïve. Both trials included various efficacy and safety measures as endpoints.
Jaypirca is a highly selective, non-covalent c inhibitor approved by the US FDA as an oral prescription medicine for various B-cell malignancies. It is administered as a once-daily 200mg dose.
CLL is a slow-growing form of non-Hodgkin lymphoma from lymphocytes and remains one of the most common forms of adult leukaemia.
Lilly recently signed a research and collaboration agreement with Swedish biopharmaceutical company BioArctic to develop a potential treatment for neurodegenerative diseases.
