The National Institute for Health and Care Excellence has recommended pirtobrutinib as an NHS treatment option in England and Wales for eligible adults with relapsed or refractory chronic lymphocytic leukaemia (CLL) who have previously received a Bruton’s tyrosine kinase (BTK) inhibitor.

The final draft guidance means the treatment, marketed as Jaypirca, will be available for patients whose disease has returned or stopped responding after treatment with a BTK inhibitor when retreatment with a covalent BTK inhibitor is not considered clinically appropriate and a commercial agreement is in place.

The decision provides an additional treatment option for a group of patients with limited alternatives after disease progression on earlier BTK-targeted therapies. Eligible patients in England are expected to gain access within 30 days, with rollout in Wales expected within 60 days.

toby eyre, consultant haematologist at Oxford University Hospital NHS Foundation Trust, said: “This approval represents a critical step forward in expanding treatment options for patients living with CLL.”

He added: “As a newly approved treatment option in this patient population, pirtobrutinib builds on the progress of BTK inhibition and provides an additional treatment option for patients in the UK with relapsed or refractory CLL, particularly in the post-covalent BTK inhibitor setting.”

The recommendation is supported by findings from the Phase 3 Bruin CLL-321 trial, which evaluated pirtobrutinib in patients previously treated with a BTK inhibitor. The study met its primary endpoint, demonstrating an improvement in progression-free survival compared with investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab.

Pirtobrutinib is a non-covalent BTK inhibitor designed to bind reversibly to its target, offering a different approach from covalent BTK inhibitors already used in CLL treatment. The medicine is taken orally once daily.

peter allen, chair of trustees at the 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.”

CLL is one of the most common forms of leukaemia in adults and is characterised by the accumulation of abnormal lymphocytes. Although many patients respond well to initial therapies, relapse is common and additional treatment options are often needed as the disease progresses.

In clinical studies, the most frequently reported adverse reactions with pirtobrutinib included neutropenia and haemorrhage, while serious events such as pneumonia and anaemia were also observed in some patients. The medicine remains subject to additional safety monitoring.

The NICE recommendation marks an important milestone for eligible patients in England and Wales by expanding access to another targeted therapy for relapsed or refractory CLL after prior BTK inhibitor treatment.