TORONTO, Ontario — January 27, 2026 — Leads & Copy — Eli Lilly Canada, Inc. has announced that Jaypirca® (pirtobrutinib, 100 mg & 50 mg tablets) is now approved and available in Canada for treating adult patients with specific forms of lymphoma.
Health Canada approved Jaypirca for use as a monotherapy in adult patients with mantle cell lymphoma (MCL) that is relapsed or refractory after at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. It is also approved for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in patients who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
The approval is based on data from the BRUIN Phase 1/2 trial, which evaluated Jaypirca as a monotherapy in patients with B-cell malignancies. The trial included patients with MCL and CLL/SLL who had previously been treated with a covalent BTK inhibitor (cBTKi). The CLL/SLL cohort also included patients who had received a BCL-2 inhibitor. Patients in the trial received Jaypirca 200 mg orally once daily until disease progression or unacceptable toxicity.
In the MCL cohort (n=74), the median age was 71 years, and patients had received a median of 3 prior lines of therapy. In the CLL/SLL cohort (n=110), the median age was 68 years, and patients had received a median of 5 prior therapies. Efficacy was assessed by independent review committees using disease-specific criteria, with overall response rate as the primary endpoint.
According to Dr. Carolyn Owen, the approval of pirtobrutinib represents an important advance for patients who currently have limited options. Dr. Owen added that the data demonstrates that pirtobrutinib can provide efficacy in patients previously treated with a covalent BTK inhibitor, potentially extending the time patients may benefit from BTK inhibition therapy. This has the potential to meaningfully improve the treatment outcome for relapsed and refractory CLL/SLL and MCL patients.
In the BRUIN trial, 57% of mantle cell lymphoma patients previously treated with a covalent BTK inhibitor achieved an overall response, with nearly 19 per cent achieving a complete response and a median duration of response exceeding 21 months. In the CLL/SLL cohort, 73% of patients responded to treatment, with responses lasting a median of 12.5 months.
Mathilde Merlet, president and general manager, Lilly Canada, stated that this is a major milestone for patients across Canada who are in urgent need of new treatment options. She added that their team has been committed to making Jaypirca available for Canadian patients with MCL and CLL/SLL, and they look forward to building on this milestone by advancing treatment options for people with hematologic malignancies.
The most common adverse reactions (ARs) to Jaypirca therapy, occurring in 20% of patients or more, were decreased neutrophil count, decreased hemoglobin, decreased platelet count, fatigue, musculoskeletal pain, decreased lymphocyte count, bruising, COVID-19, cough and diarrhea.
Lymphoma Canada chief executive officer Antonella Rizza said that until now, people living with MCL and CLL/SLL who could no longer be treated with BTK inhibitors have had limited alternatives. This approval brings a new treatment option and, along with that, new hope for people living with these lymphoma subtypes.
Jaypirca received a Notice of Compliance with conditions (NOC/c) based on response rate from the BRUIN trial, pending the results of trials to verify its clinical benefit.
Jaypirca is a highly selective kinase inhibitor that utilizes a novel binding mechanism and is the first and only approved non-covalent (reversible) BTK inhibitor. Jaypirca can reestablish BTK inhibition in MCL patients previously treated with a covalent BTK inhibitor and in CLL/SLL patients previously treated with a covalent BTK inhibitor and a BCL-2 inhibitor, extending the benefit of targeting the BTK pathway.
MCL is a rare blood cancer and a form of non-Hodgkin lymphoma (NHL). CLL is a type of blood and bone marrow cancer that primarily affects lymphocytes. CLL is very similar to SLL, the main difference being in CLL, cancerous cells collect in the blood stream and bone marrow whereas with SLL, cancerous cells collect in the lymph nodes.
Jaypirca is approved by Health Canada under a NOC/c as an oral prescription medicine, 100 mg or 50 mg tablets taken as a once-daily 200 mg dose with or without food until disease progression or unacceptable toxicity.
Jaypirca® is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.
Source: Eli Lilly Canada Inc.
