Australians newly diagnosed with the blood cancer multiple myeloma now have reason for guarded optimism.

In a landmark move, the federal government has announced that the immunotherapy drug Daratumumab (sold under the brand name DARZALEX®) will be subsidised through the Pharmaceutical Benefits Scheme (PBS) as a frontline treatment for patients who are newly diagnosed and are not eligible for stem‐cell transplantation.

The decision places Australia alongside other developed nations that are funding daratumumab up front and signals a major shift in the treatment paradigm for this often-deadly disease.

A long-awaited funding decision

For more than a decade there has been no new medicine reimbursed for newly diagnosed multiple myeloma in Australia. Now daratumumab – a first-of-its-kind CD38-directed monoclonal antibody that activates the immune system to attack myeloma cells – will enter the PBS for transplant-ineligible patients in combination with the standard agents lenalidomide and dexamethasone (the so-called “DRd” regimen).

According to clinical haematologist Professor Hang Quach of St Vincent’s Hospital Melbourne, who took part in the trials of daratumumab, Australia carries one of the highest incidence and death rates of multiple myeloma in the world. She said: “We now have a new first-line treatment option for the majority of patients diagnosed with this incurable blood cancer. This could not have come soon enough.”

The subsidy is also a relief on the cost front: without PBS support, newly diagnosed, transplant-ineligible patients would face first-year treatment costs well in excess of $150,000 and upwards of $84,000 a year thereafter. Under the new listing, eligible patients will pay as little as $7.70 per script for concession card holders, or $31.60 for general patients per month for the rest of 2025 –  and from January 2026 the general co-payment will drop to about $25 per month.

Why the change matters

Multiple myeloma is a malignancy of the plasma cells in the bone marrow. The disease disrupts normal blood cell production, weakens bones, and leaves patients prone to fractures and infection. Historically, the cornerstone of first-line treatment for eligible patients has been high-dose chemotherapy followed by autologous stem-cell transplantation. But many newly diagnosed patients – typically older, or with comorbidities – are deemed unsuitable for transplantation. For that large “transplant-ineligible” population, treatment options until now have been limited and outcomes poor. Indeed, survival rates have stagnated: roughly half of such patients die within five years of diagnosis.

Daratumumab works by attaching to CD38, a signalling molecule on the surface of myeloma cells, thereby recruiting the body’s own immune system to attack the cancer. The earlier it is given – when the patient’s immune system is stronger – the greater the potential benefit. As Professor Quach put it: “Myeloma becomes harder to treat after each relapse – it is really important that we get the initial treatment right.”

What this means for Australians

For newly diagnosed Australians with myeloma who cannot undergo transplantation, this is transformational. They will now have access to world-class therapy at the outset, rather than waiting for relapse-only access. Importantly, early intervention with the immune-activating drug may extend time to relapse, improve quality of life, and ultimately extend survival.

From a health-system perspective, earlier effective treatment may reduce downstream costs, hospitalisations, bone-related complications and associated morbidity – though economic modelling will need ongoing monitoring. The PBAC has already scheduled a drug-utilisation analysis to understand how the therapy is used in practice, how long treatment continues, and how real-world outcomes compare to trial data.

Voices from the community

Two patients illustrate the hope and frustration that has surrounded access to daratumumab.

Julie, a 74-year-old grandmother from Melbourne, was diagnosed with multiple myeloma in July. She had noticed increasing fatigue, weakness and mobility limitations which led her GP to order blood tests. A haematology work-up delivered the diagnosis: “It was devastating and I was so shocked,” she recalls. She enrolled in a clinical trial from August that included daratumumab in combination with lenalidomide and dexamethasone. A passionate bird-watcher and photographer, Julie says: “I’m not ready to fall off the perch just yet.” For her, the PBS listing is vindication: “It’s brilliant that daratumumab will be affordable … It’s a no-brainer to have it as an upfront treatment for multiple myeloma!”

David, 78, from Rushworth in regional Victoria, was diagnosed in 2016 after a back-fracture triggered further testing. He lucked into the MAIA trial and has been on daratumumab ever since: “I was one of a very lucky few able to receive Darzalex through a clinical trial. It’s like I was handed a gold nugget.” He sees the PBS decision as fairness finally catching up: “It’s nice to know that other people with myeloma will be able to receive the same medicine I have for the last ten years. That’s the way it should be.”

The road ahead

While the PBS listing for frontline daratumumab in transplant-ineligible patients marks a major milestone, challenges remain. Myeloma remains incurable: relapse is inevitable for most, and each relapse introduces greater resistance and shorter remissions. Experts say that treatment sequencing, duration and access to subsequent novel agents (such as bispecific immunotherapies and CAR-T cell therapies) will be critical. The PBAC is already examining the “evolving treatment landscape” – considering how to align PBS restrictions with clinical guidelines, how to optimise combinations, and how to maintain sustainability of the system.

Australia still has a high death rate from multiple myeloma compared with other high-income countries, so the decision to fund daratumumab early must be seen as a start, not a finish. For patients, clinicians and advocates the message is clear: start strong. By giving the best therapy at the outset, when immune function is maximal, the hope is that remissions will be deeper, longer and better for patients’ lives.