Company Announcements

• The approval of Jaypirca marks Lilly Canada's first hematology launch in Canada
• In the BRUIN Phase 1/2 trial, covalent BTK inhibitor pre-treated patients with relapsed or refractory MCL achieved an overall response rate of 57 per cent, with 19 per cent of patients achieving a complete response
• Among adults with CLL/SLL who had received at least two prior lines of therapy, including both a BTK and a BCL-2 inhibitor, the overall response rate was 73 per cent

TORONTO , Jan. 27, 2026 /CNW/ - Eli Lilly Canada, Inc announced today that Jaypirca^® (pirtobrutinib, 100 mg & 50 mg tablets) is now approved and available for use as monotherapy for the treatment of adult patients in Canada with:

• Mantle cell lymphoma (MCL) relapsed or refractory in patients who have previously received at least two lines of systemic therapy including a Bruton tyrosine kinase (BTK) inhibitor; or
• Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

Jaypirca received a Notice of Compliance with conditions (NOC/c) based on response rate from the open-label, single-arm, international, Phase 1/2 study, called the BRUIN trial,¹ pending the results of trials to verify its clinical benefit.²

Jaypirca, a highly selective kinase inhibitor, 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,^1,3 extending the benefit of targeting the BTK pathway.

The approval of Jaypirca in Canada is supported by data from BRUIN phase 1/2 trial, a global, multicenter, open-label, multi-cohort study evaluating Jaypirca as monotherapy in patients with B-cell malignancies. Two key cohorts included patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), both previously treated with a covalent BTK inhibitor (cBTKi). For the CLL/SLL cohort included in this approval, patients had also received a BCL-2 inhibitor. Patients 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 (range: 46–87), and most patients had advanced disease. They were heavily pretreated, with a median of 3 prior lines of therapy (range: 1–8).  In the CLL/SLL cohort (n=110), patients had a median age of 68 years (range: 41–88). Patients received a median of 5 prior therapies (range: 1–11), with most discontinuing cBTK therapy due to refractory or progressive disease. Efficacy in both cohorts was assessed by independent review committees using disease-specific criteria, with overall response rate as the primary endpoint.

"The approval of pirtobrutinib represents an important advance for patients who currently have limited options," said Dr. Carolyn Owen, Associate Professor in the Division of Hematology & Hematological Malignancies, University of Calgary, and a hematologist at the Arthur Child Comprehensive Cancer Centre. "These data demonstrate 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."

"This is a major milestone for patients across Canada who are in urgent need of new treatment options," said Mathilde Merlet, president and general manager, Lilly Canada. "Our team has been committed to making Jaypirca available for Canadian patients with MCL and CLL/SLL, and we look forward to building on this milestone by advancing treatment options for people with hematologic malignancies."

In the BRUIN trial, Jaypirca demonstrated meaningful activity in heavily pretreated patients. Among those with mantle cell lymphoma previously treated with a covalent BTK inhibitor, 57% 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.

The pooled safety analysis of the full BRUIN study population evaluated 593 patients with hematologic malignancies administered Jaypirca 200 mg daily as a single agent. In this pooled safety population, 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.

"Until now, people living with MCL and CLL/SLL who could no longer be treated with BTK inhibitors have had limited alternatives," said Antonella Rizza, chief executive officer, Lymphoma Canada. "This approval brings a new treatment option and, along with that, new hope for people living with these lymphoma subtypes."

About the BRUIN Phase 1/2 Trial

The BRUIN Phase 1/2 clinical trial is the ongoing first-in-human, global, multi-center evaluation of Jaypirca in patients with hematologic malignancies, including mantle cell lymphoma (MCL).

The trial includes a Phase 1 dose-escalation phase, a Phase 1b combination arm, and a Phase 2 dose-expansion phase. The primary endpoint of the Phase 1 study is maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D). Secondary endpoints include safety, pharmacokinetics (PK), and preliminary efficacy measured by overall response rate (ORR) for monotherapy. The primary endpoint of the Phase 1b study is safety of the drug combinations. The secondary endpoints are PK and preliminary efficacy measured by ORR for the drug combinations. The primary endpoint for the Phase 2 study is ORR as determined by an independent review committee (IRC). Secondary endpoints include ORR as determined by investigator, best overall response (BOR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), safety, and PK.

About Jaypirca^® (pirtobrutinib)

Jaypirca (pirtobrutinib, formerly known as LOXO-305) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.¹  BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma.^4,5

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.

About Mantle Cell Lymphoma (MCL)

MCL is a rare blood cancer and a form of non-Hodgkin lymphoma (NHL). Annually, about one in 200,000 people worldwide develop MCL.⁶ MCL arises in B lymphocytes, a type of white blood cell and part of the immune system. MCL frequently begins in B cells located in the mantle zone of the outer edge of lymph nodes. As the cancer progresses, it can spread to bone marrow, the spleen, the liver, or the digestive tract.⁵

About Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)

CLL is a type of blood and bone marrow cancer that primarily affects lymphocytes, which play an important role in the immune system. CLL is the most common type of leukemia in adults.² Over 2,200 Canadians are impacted by CLL every year.⁸ 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.²

Indications for Jaypirca

Jaypirca is a kinase inhibitor indicated as monotherapy for the treatment of adult patients with mantle cell lymphoma (MCL) relapsed or refractory in patients who have previously received at least two lines of systemic therapy including a Bruton tyrosine kinase (BTK) inhibitor. Jaypirca is also indicated for treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy including a BTK inhibitor and a BCL-2 inhibitor.

About Lilly Canada

Lilly is a medicine company turning science into healing to make life better for people around the world. Lilly has been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Lilly's Canadian Affiliate, Eli Lilly Canada Inc. was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially available insulin.

Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.

To learn more about Lilly Canada, visit www.lilly.com/en-CA, or follow us on LinkedIn.

Jaypirca^® is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

Endnotes and References

SOURCE Eli Lilly Canada Inc.