Australian Government lists BeiGene's BRUKINSA® (zanubrutinib) on the Pharmaceutical Benefits Scheme (PBS) for Patients with Mantle Cell Lymphoma1
SYDNEY, CAMBRIDGE, Mass. and BEIJING—March 1, 2022—BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company, is welcoming the listing of BRUKINSA® (zanubrutinib), a targeted treatment for mantle cell lymphoma (MCL), an aggressive and rare type of non-Hodgkin's lymphoma, on the Pharmaceutical Benefits Scheme (PBS).1 The listing will lead to improved access to the medicine from 1 March 2022 and is the first therapy from BeiGene to be subsidised by the Australian Government.
BeiGene has a long legacy in Australia. Ever since the first BeiGene study was initiated in Melbourne in 2014, the company has undertaken all its first-in-human phase 1 trials undertaken in the country – a unique proposition in the Australian pharmaceutical industry.
Dr Arthur Alston, BeiGene Executive Director, Head of Medical Affairs, Asia Pacific, says the PBS listing is a poignant moment for BeiGene, the Australian research community and the patients who participated in the studies.
"The very first patient in the world on a BRUKINSA study was enrolled in Australia in August 2014, a year after BeiGene's leadership identified Australia as a country with strong commitment to clinical trials and the capabilities to successfully conduct complex and critical first-in-human studies," said Dr Alston.
"That study was the start of the BeiGene story in Australia. While BeiGene may not be as widely known outside the medical research community as some other biotech or pharmaceutical companies, we have been quietly industrious behind the scenes and today we have had 2,200+ patients enrolled in 40+ ongoing oncology trials in Australia. This is enabled by a dedicated team of 120+ employees spread over six states, who oversee studies across 300+ sites and 90+ hospitals and clinics. The PBS approval has thrilled the team, many of whom have worked on various BRUKINSA studies for the last eight years."
In Australia, more than 6,000 people are diagnosed with non-Hodgkin's lymphoma each year, making it the sixth most common cancer in adults.3
"Australia has some of the highest rates of non-Hodgkin's lymphoma in the world, and I know Australian MCL patients will be welcoming the news today about BRUKINSA being added to the PBS," said Sharon Winton, CEO, Lymphoma Australia.
BRUKINSA is listed on the PBS as monotherapy for patients with relapsed/refractory MCL.
About BRUKINSA®(zanubrutinib)
BRUKINSA is a small molecule inhibitor of Bruton's tyrosine kinase (BTK) a protein that certain cancer cells need to survive. Because new BTK is continuously synthesised, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimising bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B-cells within a number of disease relevant tissues.
BRUKINSA is for adult patients with MCL who have received at least one prior therapy, or in first line treatments for patients unsuitable for chemo-immunotherapy.1, 2
It has been PBS listed for a second-line treatment for relapsed and/or refractory MCL with a WHO performance status of 0 or 1.
