Pirtobrutinib granted conditional marketing authorization by the UK MHRA for patients with R/R MCL or CLL

On September 1, 2025, the UK Medicines and Healthcare products Regulatory Agency granted conditional market authorization to pirtobrutinib, a non-covalent Bruton’s tyrosine kinase inhibitor (BTKi), for the treatment of patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) who were previously treated with a BTKi.¹ 

This decision was based on results from the phase III BRUIN CLL-321 trial (NCT04666038) and the phase I/II BRUIN trial (NCT03740529).¹ The authorization remains subject to ongoing regulatory review of clinical data.¹ 

Pirtobrutinib previously received a positive opinion and recommendation for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use for the treatment of patients with R/R CLL or MCL with prior BTKi exposure.² Pirtobrutinib is also approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with R/R CLL after ≥2 lines of therapy, including a B-cell lymphoma 2 inhibitor and a BTKi, and those with R/R MCL after ≥2 prior lines of therapy, including a previous BTKi.³