**Eli Lilly’s Jaypirca (pirtobrutinib) has been recommended by the European Medicines Agency’s (EMA) human medicines committee to treat chronic lymphocytic leukaemia (CLL).**
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be authorised for use in adults with relapsed or refractory CLL who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor.
Approximately 100,000 new cases of CLL, a form of slow-growing non-Hodgkin lymphoma that develops from white blood cells known as lymphocytes, are diagnosed globally every year.
Lilly’s Jaypirca is a reversible inhibitor of the BTK enzyme, which is a validated molecular target found across numerous B-cell leukaemias and lymphomas, including CLL.
The drug has already received a conditional marketing authorisation by the EMA to treat adults with relapsed or refractory mantle cell lymphoma who have been previously treated with a BTK inhibitor.
The CHMP’s new recommendation was supported by data from the phase 3 BRUIN CLL-321 trial, which met its primary endpoint of progression-free survival (PFS) and demonstrated that Jaypirca was superior to investigator’s choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR), both global standards of care for CLL.
Results from an updated analysis last year showed that Jaypirca reduced the risk of disease progression or death by 46% compared to IdelaR or BR, consistent with the primary analysis, and this PFS benefit was consistent across key subgroups, including patients who received prior venetoclax.
Jacob Van Naarden, executive vice president and president of Lilly Oncology, said: “We are pleased to receive a positive opinion from the CHMP, signalling that the EU may lead the way in broadening patient access to Jaypirca for those with relapsed or refractory CLL in the post-BTK inhibitor setting.
“There are currently no treatment options that have been specifically studied in a randomised phase 3 trial in this patient population, and we are hopeful Jaypirca will be a meaningful new option for patients.”
The European Commission will now review the CHMP’s recommendation as it makes a decision on Jaypirca in this indication, expected in the next one to two months.