Pirtobrutinib approved by Health Canada for the treatment of R/R MCL and CLL/SLL

On January 27, 2026, Health Canada granted approval to pirtobrutinib, a non-covalent Bruton’s tyrosine kinase inhibitor (BTKi), as 100 mg and 50 mg tablets for the treatment of patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) who have received ≥2 prior lines of therapy, including a BTKi, or chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL) who have received ≥2 prior lines of therapy, including a BTKi and a B-cell lymphoma 2 inhibitor (BCL-2i).¹ 

This approval is supported by data from the phase I/II BRUIN trial (NCT03740529) assessing pirtobrutinib (200 mg orally once daily) as a monotherapy in B-cell malignancies. In patients with MCL (n = 74), the overall response rate (ORR) was 57%, with ~19% achieving complete response (CR) and a median duration of response of >21 months. The ORR for patients with CLL/SLL (n = 110) was 73%, with a median duration of response of 12.5 months. In the pooled safety analysis (n = 593), the most common adverse events (AEs; occurring in >20% of patients) were decreased neutrophil count, decreased hemoglobin, decreased platelet count, fatigue, musculoskeletal pain, decreased lymphocyte count, bruising, COVID-19, cough, and diarrhea.¹ 

Pirtobrutinib is also approved by the U.S Food and Drug Administration (FDA) for the treatment of patients with R/R CLL after ≥2 prior lines of therapy, including a BTKi and a BCL-2i, and with R/R MCL after ≥2 prior lines of therapy, including a BTKi,² and by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of patients with R/R MCL or CLL who were previously treated with a BTKi.^3,4