13 October 2021 - - Brukinsa (zanubrutinib) has been approved in Australia for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy, Chinese biotechnology company BeiGene (NASDAQ: BGNE) (HKEX: 06160) said.

On October 7, 2021, Brukinsa received its initial approval in Australia for the treatment of adult patients with Waldenström's macroglobulinemia who have received at least one prior therapy or in first line treatment for patients unsuitable for chemo-immunotherapy.

Following registration of Brukinsa with the Australian Therapeutic Goods Administration in both approved indications, these patients will have immediate access to Brukinsa through the BeiGene sponsored post-approval, pre-reimbursement access program.

BeiGene submitted for reimbursement of Brukinsa to the Australian Pharmaceutical Benefits Advisory Committee, with MCL recommended for listing in July 2021.

More than 6,000 people are diagnosed with non-Hodgkin's lymphoma in Australia each year, making it the sixth most common cancer in adults.

MCL is a B-cell NHL that develops in the outer edge of a lymph node called the mantle zone.

MCL usually has a poor prognosis, with a median survival of three to six years, and is often diagnosed at a later stage of disease.

The Australian registration 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 83.7%, 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 18.4 months, the ORR was 83.7% (95% CI: 74.2, 90.8), including 68.6% CRs (FDG-PET scan required) and 15.1% 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 14.75 months, the ORR was 84.4% (95% CI: 67.2, 94.7), including 25.0% CRs (FDG-PET scan not required) and 59.4% 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, hemorrhage/hematoma, rash, bruising, anemia, musculoskeletal pain, diarrhea, pneumonia, and cough.

The most common Grade 3 or higher adverse reactions were neutropenia, thrombocytopenia, pneumonia, and anemia.

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 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.