BeiGene announces its first PBS approval for BRUKINSA® for the treatment of 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 pleased to announce that BRUKINSA® (zanubrutinib), a new treatment option for Australians with mantle cell lymphoma (MCL), an aggressive and rare type of non-Hodgkin's lymphoma, will be available to eligible patients via the Pharmaceutical Benefits Scheme (PBS) from 1 March 2022.1
One patient welcoming today's news is Peter Moon, aged 75 from Hampton Park in south-east Melbourne, who can thank regular testing for a prostate condition for alerting him to a different health issue that required immediate treatment.
An MRI found his prostate was fine, but he was devastated to learn from his doctor that he had MCL – a type of blood cancer. He was put on a six-month course of oncology medication in 28-day cycles by infusion, as well as four capsules per day of BRUKINSA. 1
"I had been experiencing a bit of fatigue and body soreness before my diagnosis but attributed it to the effects of getting older, so it was a big shock to be told I had MCL," said Moon. "After six months of the combined treatment, I ended up just on BRUKINSA, and within a couple of months I started to feel more energetic, and my spirits lifted.
"In fact, I feel better now than I have felt in years. A recent scan showed the MCL had almost gone, my spleen is back to normal, and best of all, I have a new lease of life and energy.
"I've been told I'm close to remission, which is a huge relief as it was looking pretty grim. I am so thankful to my haematologist for referring me to the Monash Health Clinical Trials Centre - where work was undertaken to determine the mutation type of the lymphoma, and after six weeks of tests and scans, they enrolled me in the BRUKINSA clinical trial under the guidance of Professor Stephen Opat and I was placed into the care of the Monash Health Clinical Trial Centre Team."
Although nearing retirement, Peter is still running a marine contracting business which he started 41 years ago and is now looking forward to some new adventures with his wife, travelling throughout the country in their caravan.
"As BRUKINSA is a tablet, I don't need to be hooked up to a device for intravenous infusions every 28 days, so I only need to be in Melbourne for my three-monthly health check-ups," he said. "We want to get out of Melbourne for the winter, so we will hit the road this year with an eye to spending some time in our favourite spots around the country.2
"I am so pleased to hear that BRUKINSA has been approved by the PBS for the treatment of MCL, as it has been a game-changer for me," he said.
Australia's role in the development of BRUKINSA
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.
While BeiGene may not be as widely known outside the medical research community as some other biotech or pharmaceutical companies, they have been quietly industrious behind the scenes and today have 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 – putting them on track to become one of Australia's largest clinical operations teams.
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 WHO performance status of 0 or 1.
