There has been a significant breakthrough in the treatment of pancreatic cancer, with the US Food and Drug Administration (FDA) approving Rasonque (daraxonrasib) - a new targeted treatment that has delivered some of the most encouraging results we have seen for people with advanced pancreatic cancer.
For Dare to Hope, and for the families who follow developments in pancreatic cancer research so closely, this is enormously exciting news.
But it also raises an urgent question:
When will Australians be able to access it?
What is Rasonque?
Rasonque, previously known by its drug name daraxonrasib, is a tablet taken once a day. It works differently from traditional chemotherapy by targeting RAS - a protein that plays a major role in driving the growth of most pancreatic cancers.
On 26 August, the FDA approved Rasonque in the United States for adults with metastatic pancreatic adenocarcinoma - the most common form of pancreatic cancer - who have already received at least one previous systemic treatment, or who are not suitable for combination systemic therapy.
The approval followed the Phase 3 RASolute 302 clinical trial involving 500 patients.
The results were remarkable.
Patients receiving Rasonque had a median overall survival of 13.2 months, compared with 6.7 months for patients receiving standard chemotherapy.
The treatment also delayed the progression of the cancer: median progression-free survival was 7.2 months with Rasonque compared with 3.6 months with chemotherapy.
Importantly, Rasonque is not a cure for pancreatic cancer. Nor will it be suitable for every patient. But in a disease where treatment advances have been painfully slow and options remain limited, these results represent genuine progress.
What does the US approval mean for Australians?
At this stage, FDA approval does not mean Rasonque is approved or routinely available in Australia.
Revolution Medicines has confirmed that Rasonque is currently approved only in the United States.
There is already important work happening here. The RASolute 303 clinical trial is recruiting Australian patients with newly diagnosed metastatic pancreatic cancer who have not yet received treatment for their advanced disease. This is a different setting from the treatment that has just received FDA approval in the US.
But since news of the FDA approval, Dare to Hope has begun receiving enquiries from Australian families wanting to know how their loved ones can access Rasonque now.
We understand that urgency.
When you love someone with pancreatic cancer, being told that a treatment exists that could potentially give them more time - but that it is available in another country and not yet routinely accessible here - is incredibly difficult.
That is why Dare to Hope is advocating with Revolution Medicines and the Australian Government to understand what needs to happen to make Rasonque available to eligible Australian patients as quickly as possible.
We want to see everyone involved - the manufacturer, regulators and government - working with the same urgency that patients and their families live with every day.
Dare to Hope's position
Cherie Dear, CEO and Co-Founder of Dare to Hope, said:
“The FDA approval of Rasonque (daraxonrasib) is an extraordinary development for people with pancreatic cancer and represents the kind of progress families affected by this disease have waited far too long to see.
“For decades, treatment options for pancreatic cancer have remained extremely limited.
“Since the FDA approval was announced, Dare to Hope has already received enquiries from Australian families wanting to know how their loved ones can access this treatment here. That tells us just how urgently new options are needed.
“Australian patients should not have to watch a potentially life-extending treatment become available overseas and wonder when - or whether - they will be able to access it here.
“For people facing an aggressive cancer like pancreatic cancer, time is simply not on their side. To know there is now a treatment that has been shown to extend life, but not know when or how you might be able to access it in Australia, is incredibly distressing.
“We know there are clinical trials of Rasonque underway in Australia, yet families are struggling to find clear information about where those trials are available and whether their loved one may be eligible. Now the drug has been approved in the US and will be available to eligible patients outside a clinical trial, those questions have become even more urgent.
“Families understand that there are regulatory processes that need to happen in Australia. What they need now is clear, accessible information about what the pathway is, what options exist today, and when broader access might realistically be possible.
“When someone you love has pancreatic cancer, there is already so much that is beyond your control. Information is one thing we can give people. No family should be left searching for answers about a potentially life-extending treatment while the clock is ticking.”
“We are calling on all parties involved - including the Australian Government, regulators and Revolution Medicines - to work with urgency to establish a pathway to make Rasonque accessible to eligible Australian patients as quickly as possible.
“For people living with pancreatic cancer, months matter. Time with family matters.
“This approval shows that progress against pancreatic cancer is possible. Our job now is to make sure Australians are not left waiting for it.”
What happens next?
Dare to Hope is seeking further information from Revolution Medicines and the Australian Government about the pathway towards Australian access to Rasonque.
We will continue to advocate for urgency and will share reliable information with the pancreatic cancer community as it becomes available.
For Australian families contacting us now, we know that this is not simply a story about an exciting new drug.
It is a question of time - and whether a treatment that can give some people more of it can reach Australians who need it soon enough.
