Pankind leads access push to first pancreatic cancer therapy in 40 years

A first-in-class RAS(ON) inhibitor marks a profound paradigm shift in pancreatic cancer care, succeeding where four decades of research failed by directly targeting RAS, long regarded as “undruggable”. Yet despite the global excitement surrounding this scientific milestone, Australian patients remain unable to access the therapy.

For a disease with a five-year survival rate in Australia of just 14%, the findings of the RASolute 302 trial represent the first validated therapeutic advancement in decades.

Presented at ASCO 2026, the trial evaluated daraxonrasib as a second-line treatment in metastatic pancreatic cancer following one prior course of chemotherapy. The study demonstrated a near doubling in median overall survival compared with chemotherapy alone, extending survival to 13.2 months versus 6.7 months, while delivering a 60% reduction in the risk of death (P<0.0001). Principal investigator, Dr Brian Wolpin, described the therapy as a “dramatic shift” in the treatment of pancreatic cancer.

The patient advocacy group, Pankind, has been actively engaging with regulators and the Health Minister’s office to explore measures that could position Australia as a more attractive launch market for Revolution Medicines’ daraxonrasib.

“We describe this moment as the best of times and the worst of times. It is the best of times because the science is real. There was a standing ovation when these results were presented at the ASCO plenary, and it represents the biggest shift pancreatic cancer treatment has seen in decades,” Michelle Stewart, CEO of Pankind told Health Industry Hub. “But it is the worst of times because that excitement has not yet translated into a treatment option Australian patients can actually receive. Many of these patients are already very unwell, which makes the delay especially cruel. For them, this isn’t an abstract regulatory or commercial timeline. It’s the difference between spending precious time with their families or not.”

Through its representation on the World Pancreatic Cancer Coalition Steering Committee, Pankind said the race to secure access to daraxonrasib is a global conversation, with countries seeking to ensure their patients are not left behind.

“That’s understandable in a disease with such limited treatment options. But it means we have to fight hard on behalf of the Australian patients affected by this disease, rather than assume our turn will come,” emphasised Stewart.

Earlier this year, in the absence of a local presence for Revolution Medicines in Australia, Pankind approached the global organisation directly and offered support with the Therapeutic Goods Administration (TGA) registration process.

Senior pharmaceutical executive, Neil MacGregor, was recently appointed as the Senior Vice President and General Manager of JAPAC at Revolution Medicines. He has since engaged with the World Pancreatic Cancer Coalition and provided an update on the company’s future research plans. Yet, details of its Australian regulatory strategy has not been disclosed.

“Now that Revolution Medicines has a local presence, our role is shifting. We’re supporting the local team to help accelerate registration, rather than trying to do it in their place,” said Stewart.

Alongside patient advocacy efforts, Australia’s medical oncology community has also been pushing for earlier patient access through compassionate access. While that pathway was opened in the United States within two days of the trial results being presented, Australian patients currently do not have an equivalent option available.

Regulators in other major jurisdictions are also moving with notable urgency. In the United States, daraxonrasib is being reviewed under the Commissioner’s National Priority Voucher program, which aims to compress the standard 10 to 12-month review period to a target of one to two months from filing to regulatory action. In Europe, the therapy has been granted orphan medicinal product designation for pancreatic cancer and recognised as a high-priority medicine under the European Medicines Agency’s Cancer Medicines Pathfinder project.

Australia has comparable regulatory mechanisms, including priority review pathways and international work-sharing initiatives such as Project Orbis, which can meaningfully reduce TGA assessment timelines when appropriately leveraged. However, securing a Pharmaceutical Benefits Advisory Committee (PBAC) recommendation and, ultimately, PBS listing remains a more complex and protracted process.

For patients like Dee who is living with pancreatic cancer, those timelines are measured differently.

What began as a busy month balancing work and family quickly became a life-changing journey when Dee was diagnosed with pancreatic cancer at just 48 years of age. The diagnosis came at the worst possible moment when her husband was overseas and unreachable, her teenage daughters were at home, and the future they had envisioned changed in an instant.

After undergoing major surgery, months of gruelling chemotherapy and dramatic weight loss, Dee hoped to hear she was cancer-free. Instead, a routine scan revealed the devastating news that the cancer had already spread. Even after receiving a terminal diagnosis, she refused to let statistics define her, choosing instead to place her hope in a groundbreaking clinical trial that has given her renewed optimism and purpose.

Perhaps the most remarkable part of Dee’s story is not only her resilience but the community that has rallied around her. Friends, neighbours, colleagues, school parents and even strangers have stepped forward without hesitation, delivering meals, driving her to appointments, supporting her family and ensuring she never faces the disease alone. Today, as she prepares for a long-awaited trip to Europe to celebrate her 50th birthday, Dee embodies the possibility that hope can coexist with heartbreak, and that the strength of a community can carry someone further than they ever imagined.

“We need Australia to open compassionate access now, while fast-tracking formal registration in parallel. Every month of delay here is measured in lives, not paperwork,” stressed Stewart.

A first-line trial of daraxonrasib in metastatic pancreatic cancer is expected to commence in Australia shortly. However, that study offers little immediate benefit to the substantial proportion of patients who relapse after initial treatment, the reality for most people diagnosed with pancreatic cancer.

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