Government funds first-of-its-kind
blood cancer fighting medicine
Sydney, Australia 28 December, 2020 - Federal Government funding for a first-in-class medicine to treat a common and deadly form of blood cancer, multiple myeloma, by activating the patient's immune system to identify and kill cancer cells,is being welcomed by medical experts, patients and the Janssen Pharmaceutical Companies of Johnson & Johnson.
From 1 January 2021, Darzalex® (daratumumab) will become available on the Pharmaceutical Benefits Scheme (PBS) for Australians with multiple myeloma whose disease progresses after initial treatment. It will be used in combination with existing medicines, bortezomib and dexamethasone, after one prior line of treatment.
Darzalex will be the first new type of medicine for multiple myeloma to be added to the PBS in more than a decade. It is a targeted therapy that works by attaching to a specific protein on the surface of a multiple myeloma cell, and by doing so triggers the patient's immune system to attack and destroy multiple myeloma cancer cells.
An estimated 1,000 Australians will be eligible for treatment with Darzalex each year. Eligible patients will now pay $41.30 (general patients) or $6.60 (concessional patients) for each phase of treatment*.
Multiple myeloma is an incurable blood cancer that affects plasma cells found in the bone marrow. More than 2,000 new cases of multiple myeloma are expected to be diagnosed in Australia this year and approximately 1,000 people will lose their lives to the disease.
Professor Andrew Spencer, Head of the Malignant Haematology & Stem Cell Transplantation Service at The Alfred Hospital in Melbourne, and one of the doctors involved in Australian clinical trials of Darzalex, welcomed the new subsidy, citing the serious need for new medicines to combat multiple myeloma.
"Multiple myeloma is a very challenging cancer to treat. It is associated with high rates of relapse, treatment resistance, and poor prognosis," he said.
"After years of research, we now have an entirely new type of treatment to suppress the cancer during a critical window - when a patient no longer responds to initial treatment or their cancer returns after initial treatment," he said.
Professor H. Miles Prince AO, Director of Molecular Oncology and Cancer Immunology, Epworth Healthcare and of the Centre for Blood Cell Therapies at the Peter MacCallum Cancer Centre, explained that the five-year survival rate for people with multiple myeloma is just 51 per cent meaning "approximately one in two patients will die within five years of their diagnosis".
"Darzalex is a novel medicine that targets the Achilles' heel of the myeloma cancer cell, while simultaneously activating the body's immune system to attack the cancer," he said.
"This is the first time we have been able to directly target myeloma cancer cells, while also putting the immune system to work against the cancer."
According to Myeloma Australia CEO, Steve Roach, Darzalex represents "the first major development in the way multiple myeloma is treated in more than 10 years".7
"Multiple myeloma claims the lives of far too many Australians. Patients and their families understand this reality. The PBS listing of Darzalex means access to a much-needed treatment without financial burden for eligible patients. This is a major milestone that will be warmly welcomed across the country," he said.
Bruce Goodwin, Managing Director, Janssen Australia and New Zealand, said: "Our company has a long and proud history in the treatment of multiple myeloma. The PBS listing of Darzalex gives doctors and patients a new way to fight this less common and deadly form of blood cancer".
"The Federal Government is to be commended for its significant investment in making important new medicines like Darzalex accessible to Australians in need," he said.
Darzalex was first approved in 2017. More than 1,000 Australians have been treated with Darzalex.
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About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects plasma cells found in the bone marrow. Myeloma affects multiple (hence 'multiple myeloma') places in the body where bone marrow is normally active in adults, including within the bones of the spine, skull, pelvis, rib cage, and the areas around the shoulders and hips.
As the cancer cells grow and spread, they can lead to bone pain and breakages, frequent infections, kidney damage and anaemia.
The disease has a poor prognosis and each year claims around 1,000 Australian lives. Multiple myeloma is characterised by high rates of relapse,even if initial treatment results in remission. Typically, the cancer becomes more aggressive and more challenging to treat following each relapse.
About Darzalex
Darzalex is a first-in-class immunotherapy known as a CD38-directed monoclonal antibody. The therapy works by binding to CD38, a signalling molecule on the surface of multiple myeloma cells. In doing so, Darzalex triggers the patient's immune system to attack cancer cells, resulting in tumour cell death.
Based on extensive research, Darzalex is indicated for the treatment of multiple myeloma either alone or in combination with other therapies at various stages of the disease. Darzalex will become available through the PBS for treatment in combination with bortezomib and dexamethasone for patients with multiple myeloma after one prior line of treatment.
Darzalex is administered by infusion – initially every week, then once every three weeks and then monthly until the cancer progresses.
All medicines may have side-effects. Darzalex may cause infusion-related reactions and may increase the incidence of upper respiratory tract infections. Other possible side effects observed when Darzalex is used in combination with bortezomib and dexamethasone are decreases in blood cell counts, peripheral sensory neuropathy, diarrhoea, cough, fatigue, constipation, and back pain.
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