Eli Lilly and Company has received conditional marketing authorisation from the MHRA for pirtobrutinib (Jaypirca ▼) as monotherapy for adults with relapsed or refractory mantle cell lymphoma (MCL) or chronic lymphocytic leukaemia (CLL) previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor.
The decision is based on data from two clinical trials: BRUIN CLL-321, the first randomised phase 3 trial in CLL exclusively involving patients previously treated with a BTK inhibitor, and BRUIN, a phase 1/2 study in B-cell malignancies including MCL.
Pirtobrutinib is a reversible BTK inhibitor designed to address treatment resistance in patients who have progressed on covalent BTK therapies. The approval provides a new option for patients with limited alternatives.
Toby Eyre, Consultant Haematologist at Oxford University Hospital NHS Foundation Trust, said: “As a newly licensed treatment option, pirtobrutinib provides an additional treatment option for eligible patients in the UK with relapsed or refractory MCL and CLL, particularly in the post-covalent BTK inhibitor setting.”
Hilary Lindsay, Chair of Trustees at CLL Support Association, said: “For people living with chronic lymphocytic leukaemia (CLL), the availability of additional treatment options can make a difference. Every new option means greater choice for patients and their healthcare teams. We know how important it is for treatments like this to reach eligible patients.”
Holly Thomas, Associate Vice-President of Specialty Care at Lilly UK & Ireland, added: “Lilly is committed to continuing the development of pirtobrutinib and continuing to bring forward new treatments for people with haematologic malignancies.”
The authorisation remains subject to ongoing regulatory review of clinical data.
