
Lilly secures conditional MHRA approval for new blood cancer treatment
Ella Day | September 1, 2025 | News story | |
The UK’s Medicines and Healthcare products Regulatory Agency has granted conditional marketing authorisation for Eli Lilly’s pirtobrutinib (Jaypirca). This new therapy is for adults with relapsed or refractory mantle cell lymphoma (MCL) or chronic lymphocytic leukaemia (CLL) who have previously received a Bruton’s tyrosine kinase (BTK) inhibitor.
The approval is supported by results from two major clinical studies: the phase 3 BRUIN CLL-321 trial in CLL patients previously treated with a BTK inhibitor and the phase 1/2 BRUIN study in MCL. Both trials demonstrated that pirtobrutinib slowed disease progression and produced durable responses in patients who had few remaining treatment options.
Toby Eyre, consultant haematologist at Oxford University Hospitals NHS Foundation Trust, Oxford, UK, commented: “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.”
Patient organisations have also welcomed the development. Hilary Lindsay, chair of trustees at the CLL Support Association in Chippenham, UK said: “For people living with CLL, the availability of additional treatment options can make a difference. Every new option means greater choice for patients and their healthcare teams.”
Pirtobrutinib is BTK inhibitor designed to overcome resistance to existing therapies. While CLL affects around 4,000 people each year in the UK, MCL is rarer, with about 600 new cases annually.
Ella Day







