BY: Phillip McLeod
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of pirtobrutinib (Jaypirca) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor. This recommendation was announced on February 28, 2025.
Pirtobrutinib is an oral therapy administered once daily, according to the press release from Lilly, the manufacturer of the therapy.
The CHMP’s recommendation is based on results from the phase 3 BRUIN CLL-321 trial, which evaluated pirtobrutinib against investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab in patients previously treated with a covalent BTK inhibitor.
In the trial, pirtobrutinib demonstrated a 46% reduction in the risk of disease progression or death compared to the control arm, according to the company.
