Policy & Regulation
Brukinsa Approved in Canada for the Treatment of Patients with Mantle Cell Lymphoma
27 July 2021 - - Brukinsa (zanubrutinib) has been approved by Health Canada for the treatment of mantle cell lymphoma in adult patients who have received at least one prior therapy, Chinese biotechnology company BeiGene, Ltd. (NASDAQ: BGNE) (HKEX: 06160) said.

This is the second approval for Brukinsa in Canada, following its initial approval in March 2021 for adult patients with Waldenström's macroglobulinemia.

The Health Canada approval for Brukinsa in MCL is based on efficacy results from two single-arm clinical trials.

Across both trials, as assessed by independent review committee per 2014 Lugano Classification Brukinsa achieved an overall response rate of 84%, defined as the combined rate of complete responses and partial responses.

In the multicenter Phase 2 trial of zanubrutinib in patients with relapsed or refractory MCL BGB-3111-206 (NCT03206970), with a median follow-up time of 18.5 months, the ORR was 84% (95% CI: 74, 91), including 69% CRs (FDG-PET scan required) and 15% PRs; the median duration of response was 19.5 months (95% CI: 16.6, NE).

In the global Phase 1/2 trial BGB-3111-AU-003 (NCT02343120), with a media follow-up time of 18.8 months, the ORR was 84% (95% CI: 67, 95), including 25% CRs (FDG-PET scan not required) and 59% PRs; the median DoR was 18.5 months (95% CI: 12.6, NE).

Of the 118 patients with MCL who received at least one prior therapy and received BRUKINSA treatment, 13.6% of patients discontinued treatment due to adverse events in the trials, with the most frequent being pneumonia.

Adverse events leading to dose reduction occurred in 3.4% of patients, including hepatitis B, neutropenia, allergic dermatitis, and peripheral sensory neuropathy (in one patient each).

The overall safety profile of Brukinsa is based on pooled data from 779 patients with B-cell malignancies treated with Brukinsa in clinical trials.

The most common adverse reactions with Brukinsa were neutropenia, thrombocytopenia, upper respiratory tract infection, anemia, rash, musculoskeletal pain, diarrhea, cough, contusion, pneumonia (grouped terms), urinary tract infection, hemorrhage (grouped terms), and hematuria.

Overall, 18% of patients experienced serious adverse reactions. The most frequent serious adverse reactions were pneumonia (10.0%) and hemorrhage.

The recommended dose of Brukinsa is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.

Brukinsa is available in Canada for the treatment of MCL and Waldenström's macroglobulinemia through the myBeiGene patient support program, established to support patients, caregivers, and health care providers.

Mantle cell lymphoma is a B-cell non-Hodgkin lymphoma. It develops in the outer edge of a lymph node called the mantle zone.

Mantle cell lymphoma occurs more often in men than in women. It is usually diagnosed in people in their early 60s.

Approximately one out of 200,000 individuals per year are diagnosed with MCL. MCL usually has a poor prognosis, with a median survival of three to four years, and is often diagnosed at a later stage of disease.

Brukinsa is a small molecule inhibitor of Bruton's tyrosine kinase discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.

With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

The myBeiGene patient support program is designed to support patients, caregivers, and healthcare providers with access to Brukinsa.

It goes beyond financial assistance support to provide patients and caregivers with education about their disease and treatment with Brukinsa, as well provide practical and emotional support by connecting them to third-party resources that can address their individual needs.