Daraxonrasib in Canada
Now
It was a win worth celebrating. In August 2026, the U.S. FDA approved daraxonrasib — the first targeted therapy for metastatic pancreatic cancer — after a phase 3 trial in which patients lived a median of 12.4 months, compared with 6.7 months on chemotherapy. The announcement sent a collective sense of enthusiasm and relief throughout the pancreatic cancer community- progress was finally on the horizon.
Since then, we have combed through more than 2,000 Reddit posts and comments from Canadians wanting a chance at another treatment option, asking the same questions: What is the status of this drug in Canada? How do I get access? How long before it is available here?
The honest answer is that a long path to approval lies ahead. Daraxonrasib (also known as RMC-6236, sold in the United States as Rasonque) has not been submitted to Health Canada for review, and until further clinical trials are offered in Canada, there is no feasible way for most Canadians to access it yet. Two trials are now recruiting in Canada: RASolute 303 for first-line metastatic disease, and RASolute 304 for patients who have had surgery to remove the cancer.
RASolute 303 is for first-line treatment of metastatic pancreatic cancer. A second trial, RASolute 304, is for patients who have had surgery to remove the cancer — it is described below. Access outside a trial requires separate confirmation and authorization.
This page tracks the drug's real status in Canada: the four steps it still has to clear, what the timelines actually look like, and the access routes that do and do not work.
About daraxonrasib (RMC-6236)
Daraxonrasib is an oral RAS inhibitor developed by Revolution Medicines. It blocks proteins involved in cancer growth. Its development name is RMC-6236, and its U.S. brand name is Rasonque.
The U.S. FDA approved daraxonrasib on August 26, 2026, for adults with metastatic pancreatic adenocarcinoma—pancreatic cancer that has spread—who have received at least one previous systemic treatment or cannot receive treatment involving multiple cancer drugs.
On October 15, the European Medicines Agency’s expert committee recommended EU approval for previously treated metastatic pancreatic cancer. The European Commission’s final decision was still pending in the latest update. Neither decision automatically authorizes the drug in Canada.
What did the clinical trial show?
The European update reported median survival of 12.4 months with daraxonrasib compared with 6.7 months with chemotherapy in previously treated patients. “Median” means half the patients lived longer and half lived less time. It does not predict an individual person’s outcome.
Some reports cite 13.2 months, the figure in the FDA’s August approval summary. The figures come from different reported analyses and should be read alongside their source.
Current clinical trials in Canada
RASolute 303 — first-line treatment for metastatic disease
RASolute 303 studies daraxonrasib alone or with gemcitabine and nab-paclitaxel as a first-line treatment for metastatic pancreatic adenocarcinoma. It is one of two daraxonrasib trials we currently have confirmed as recruiting at Canadian sites.
First-line means patients have not yet received systemic treatment for their metastatic disease. This is not a trial for accessing daraxonrasib after first-line treatment has stopped working. Previous chemotherapy before or after surgery needs to be assessed by the study team.
The latest trial record lists recruiting Canadian sites at:
- Princess Margaret Cancer Centre, Toronto.
- Sunnybrook Research Institute, Toronto.
- McGill University’s oncology clinical research program, Montreal.
The trial compares daraxonrasib alone, daraxonrasib with chemotherapy, and chemotherapy alone. Treatment is randomly assigned, so joining does not guarantee receiving daraxonrasib.
Eligibility, recruitment status and available spaces should be confirmed directly before making travel plans.
Trial contact: Revolution Medicines — 1-844-2-REVMED. Ask about RASolute 303, study number NCT07491445. Your oncologist can help with eligibility and referrals.
RASolute 304 — after surgery
RASolute 304 studies daraxonrasib versus observation in patients whose pancreatic cancer has been surgically removed (an R0 or R1 resection). It tests whether taking daraxonrasib after surgery helps keep the cancer from coming back. Treatment is randomly assigned, so joining does not guarantee receiving daraxonrasib.
It is for patients who completed multi-agent chemotherapy around their surgery within the past 12 weeks and who have no recurrent or metastatic disease. This trial is not an access route for metastatic patients.
The latest trial record lists recruiting Canadian sites at:
- Princess Margaret Cancer Centre, Toronto.
- McGill University Health Centre, Montreal.
Trial contact: Revolution Medicines — 1-844-2-REVMED. Ask about RASolute 304, study number NCT07252232. Your oncologist or surgical team can help with eligibility and referrals.
Access outside a clinical trial
We have not independently confirmed a Canadian patient receiving daraxonrasib outside a trial through the routes below.
Health Canada’s Special Access Program
Health Canada’s Special Access Program, or SAP, allows a treating doctor to request a drug unavailable for sale in Canada for someone with a serious or life-threatening condition when usual treatments have failed, are unsuitable or are unavailable.
Health Canada must authorize the request, and the manufacturer must agree to supply the medication. Submitting a request does not guarantee access, and authorization does not mean treatment will be free or covered.
Ask your oncologist whether a SAP request is appropriate and whether Revolution Medicines would support supply for a Canadian patient.
Everyone.org and international access
With access to Daraxonrasib still months and if not years out, Canadians are looking for alternatives. Everyone.org has come up in the Reddit discussions we have been following. Some discussions refer to announcements that daraxonrasib is available to order outside the United States.
Everyone.org lists Rasonque through its international medicine-access service. It describes itself as a Netherlands-registered pharmaceutical wholesaler working with partner pharmacies, rather than a Canadian pharmacy. A prescription is required, and additional authorization or import paperwork may be necessary.
We have not independently verified successful Canadian access through this service. Its inclusion here is informational—not an endorsement or confirmation of an established Canadian access route.
Can Canadians receive assistance through (ON)Path?
(ON)Path is Revolution Medicines’ U.S. patient-support program. It helps eligible patients with insurance, financial-assistance options and treatment support.
Its published rules say services are available to U.S. residents only. It should not be presented as a Canadian access or financial-assistance program for people living in Canada.
The restriction concerns residency, not simply citizenship. A Canadian living in the United States would need the program to assess their eligibility and any additional assistance requirements.
What about U.S. expanded or compassionate access?
Do not assume a U.S. access program accepts Canadian residents. Your oncologist should confirm current options directly with Revolution Medicines, including whether the company can support a Canadian SAP request.
An enquiry, a quote, an application, authorization and actual medication delivery are different stages. We will distinguish between them when sharing updates.
Canadian access requirements
Approval in the U.S. does not mean a drug is approved in Canada. Access outside a Canadian trial requires the appropriate authorization and a supplier willing to provide it. A prescription or international price quote alone does not confirm access.
The SAP guidance explains the responsibilities of the treating practitioner, Health Canada and the manufacturer.
We will update this article if a Canadian access route is confirmed.
Free testing through My CANcer Code
My CANcer Code, offered by Pancreatic Cancer North America with OncoHelix, provides free genomic testing to eligible pancreatic cancer patients. A doctor must order it, and eligibility conditions apply.
OncoHelix’s patient information states that New Brunswick patients are excluded because a comprehensive publicly funded testing panel is already available in the province. Ask your oncology team about the provincial option instead.
Daraxonrasib cost and coverage in Canada
The reported U.S. list price is approximately US$39,800 for a 30-day supply. That is not a Canadian price, an international supplier’s quote or necessarily what an insured U.S. patient pays.
International purchases may involve additional fees, shipping and taxes. SAP authorization does not guarantee reimbursement, so coverage should be confirmed in writing before committing to costs.
Side effects and safety
The FDA’s approval information identifies important risks including skin reactions, mouth inflammation or sores, diarrhea, serious bowel complications and lung inflammation. Your care team should explain monitoring and which symptoms need urgent attention.
Frequently asked questions
What steps are needed before daraxonrasib can be approved and publicly funded in Canada?
Xianjie Li
Approval and coverage are separate decisions. The usual pathway is:
- Health Canada review. The manufacturer submits evidence, and Health Canada assesses safety, effectiveness and manufacturing quality before deciding whether to authorize sale.
- Public-funding assessment. Canada’s Drug Agency, formerly CADTH, reviews clinical benefits and value for money and makes a funding recommendation. Quebec uses INESSS. This work can overlap with Health Canada’s review.
- Price negotiations. The pan-Canadian Pharmaceutical Alliance, or pCPA, may negotiate pricing and other terms with the manufacturer for participating public drug plans.
- Coverage decisions. Individual public plans decide whether to fund the drug and who qualifies. Coverage does not necessarily begin everywhere at once.
Typical times, for context: Health Canada targets 300 days for a standard review (180 days for priority review). Canada’s Drug Agency recently took a median of 206 days to make its recommendation (2024 data), and its new streamlined process targets 180 days as of 2026. Price negotiations typically add about four months for the pCPA to decide whether to negotiate, plus four to five months at the table. Across all four steps, recent cancer drugs have taken about two years on average from Health Canada approval to public funding.
Health Canada approval does not automatically mean public coverage, and there is no guaranteed timeline for the full process. These are the general steps—not confirmation of daraxonrasib’s current status at every stage.
Can I join RASolute 303 after first-line treatment stops working?
RASolute 303 is a first-line trial for metastatic disease, not a later-line access route. If you have already received treatment for metastatic pancreatic cancer, ask your oncologist about other options.
Can my doctor simply prescribe daraxonrasib and order it from abroad?
A prescription is required for services such as everyone.org, but it is not the only requirement. Canadian authorization, import arrangements, supply, cost and medical monitoring also need to be resolved.
Does SAP authorization mean the drug is free?
No. It does not require the manufacturer to supply the medication or establish insurance coverage. Supply and payment must be confirmed separately.
Is (ON)Path available to patients living in Canada?
Its published rules limit services to U.S. residents. It is not a confirmed Canadian financial-assistance route.
What are the common side effects of daraxonrasib?
The FDA's approval information identifies important risks: skin reactions, mouth inflammation or sores, diarrhea, serious bowel complications and lung inflammation. Your care team should explain monitoring and which symptoms need urgent attention.
Share an update
If you have reliable information or firsthand experience with Canadian access, please email feedback@heathercutler.ca.
You can also join the Canadian discussion at r/CanPancreaticCancer.
We will update this article should anything change, distinguishing confirmed developments from options still being investigated.
This article provides community-shared information, not medical advice. Always speak with your oncologist about treatment decisions, access requests and side-effect management.
