New Pill for Advanced Pancreatic Cancer

What this is, in one page

Rasonque (generic name daraxonrasib, also called RMC-6236) is a once-daily tablet. It is the first FDA-approved drug in a new class: a RAS(ON) inhibitor. RAS is a protein that acts like a stuck-on growth switch in most pancreatic adenocarcinomas. This pill is built to turn that switch off while it is in the “on” (GTP-bound) state, across several RAS types — not only one rare mutation.

On 26 August 2026, the US Food and Drug Administration approved it. The full labelled indication:

RASONQUE is indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.

In plain language: adults with metastatic pancreatic adenocarcinoma who have already had at least one systemic (whole-body) cancer treatment, or who cannot have multiagent (combination) chemotherapy.

The approved dose is 300 mg by mouth once a day, with or without food, until the cancer grows or side effects become too much. Tablets come as 100 mg and 150 mg.

You do not need a RAS mutation test to match the FDA indication. That is not a companion diagnostic on the US label.

RASolute 302 (and the recruiting first-line trial, 303) did require documented RAS status — mutant or wild-type — as a trial eligibility rule. That is not a labelling CDx. About 92% of people in 302 had a KRAS G12 mutation. Genomic testing can still help your team look for other targets; do not wait on a test if you already fit the approved indication.

Canada: this drug is not confirmed as approved or sold here. See Access, below, before you assume a pharmacy or a local trial can get it.

Where this is taking place

• RASolute 302 (NCT06625320, pivotal, active but no longer taking new patients): 60 sites in United States, France, Germany, Italy, Japan, Spain, Puerto Rico. No Canadian sites.
• RASolute 303 (NCT07491445, first-line, recruiting): on 10 October 2026, ClinicalTrials.gov listed 3 recruiting sites in Canada, plus recruiting sites in the United Kingdom, Japan, Australia, South Korea, Italy, Taiwan, Spain, Belgium, Brazil, the Netherlands, Singapore, Austria, Germany and Hong Kong. All 21 US sites are listed as active, not recruiting, which means they are not taking new patients.
• US/PR expanded access (NCT07573215): United States and Puerto Rico only (status approved for marketing).
• Commercial marketing: United States only as of 2 Sep 2026.

Approval matrix (metastatic PDAC)

Pronunciation on the FDA Medication Guide: RAS-ON-cue.

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What the trial showed (plain numbers)

Approval rests on RASolute 302 (ClinicalTrials.gov NCT06625320), a phase 3, open-label, randomized trial of 500 adults with metastatic pancreatic adenocarcinoma whose cancer had grown after one prior line of treatment (a fluoropyrimidine-based or gemcitabine-based regimen). People were assigned 1:1 to daraxonrasib 300 mg daily or to the investigator’s choice of standard chemotherapy (mFOLFIRINOX, gemcitabine plus nab-paclitaxel, FOLFOX, or nal-IRI plus 5-FU/leucovorin). No crossover was built into the design described in the label.

Results in the overall population (FDA label and FDA approval summary):

The hazard ratio for death was 0.40 (95% CI 0.30–0.53; p < 0.0001): a lower chance of dying at any given time point on the curve, not a guarantee of 13 months. About 92% of people in the trial had a KRAS G12 mutation; a small group had other RAS changes or no RAS mutation found on local testing. Benefit was also shown in the RAS G12 group (median overall survival 13.2 vs 6.6 months).

These numbers come from people well enough for a trial (ECOG 0 or 1, able to swallow pills, no known brain metastases). They are not a personal prediction.

The same results were published in the New England Journal of Medicine on 31 May 2026 (print issue volume 395, pages 325–337) and presented the same day in the ASCO Plenary by Brian M. Wolpin, MD, MPH, Dana-Farber Cancer Institute.

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Research team

ClinicalTrials.gov does not name a Canadian site investigator for this program.

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Who it is for — and who it is not

More likely to fit the FDA label if all of these are true:

• Adult with metastatic pancreatic adenocarcinoma (the common type that starts in the ducts).
• Already treated with at least one systemic regimen, or your team does not consider you a candidate for combination chemotherapy.
• You can take tablets. Prior Whipple surgery does not automatically rule you out (that is stated for the US expanded-access protocol; your own team still decides).

The pivotal trial did not include (so extra caution, not a yes/no from this article):

• Age under 18 (safety in children is unknown).
• ECOG performance status 2 or higher (trial required 0 or 1).
• Known or history of central nervous system (brain/spine) metastases.
• Prior direct RAS-targeted therapy.
• Pregnancy: the label warns of embryo-fetal harm. Effective contraception is advised during treatment and for 1 week after the last dose, for women who can become pregnant and for men with partners who can. Do not breastfeed during treatment and for 1 week after.

If you have not yet had treatment for metastatic disease, this FDA approval is not a first-line licence. A separate trial, RASolute 303 (NCT07491445), is testing daraxonrasib alone or with gemcitabine plus nab-paclitaxel versus chemotherapy as first-line therapy. On 10 October 2026, ClinicalTrials.gov listed that trial as recruiting at 3 sites in Canada and in other countries. Its US sites are not taking new patients.

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Side effects you should plan for

This is not “chemo in a pill,” but it is not gentle. The label has no boxed warning. Its warnings and precautions are:

1. Skin and soft-tissue reactions — rash is very common (87% in the trial; 13% grade 3–4). The label tells clinics to start prevention on day one: steroid cream on face and chest, moisturiser, sun protection (SPF 30+), and consider a preventive oral antibiotic such as doxycycline or minocycline. Ask for a dermatology contact before the first dose.
2. Mouth sores (stomatitis) — 56% in the trial (12% grade 3–4). Steroid mouthwash and other mouth care are used. Tell the team if eating, talking, or swallowing gets hard.
3. Diarrhea — 67% (7% grade 3–4). Have an anti-diarrheal plan on paper before you start.
4. Hole in the stomach or intestine (gastrointestinal perforation) — uncommon (0.9%), can be fatal. Severe or lasting belly pain, vomiting blood, or black stool is an emergency.
5. Lung inflammation (ILD / pneumonitis) — uncommon (2.4%), can be fatal. New cough, shortness of breath, or wheeze needs same-day contact.
6. Harm to an unborn baby.

Most common side effects (≥20%): rash, diarrhea, mouth sores, nausea, fatigue, vomiting, abdominal pain, swelling, decreased appetite, and bleeding.

In RASolute 302, 2.9% stopped Rasonque for side effects, versus much higher chemo discontinuation in the NEJM safety analysis (treatment-related discontinuations 1.2% vs 11.2%). Doses can be lowered to 200 mg then 150 mg; the label says stop if 150 mg is not tolerated.

Drug interactions matter. Daraxonrasib is a CYP3A and P-gp substrate. Some antifungals, antibiotics, seizure medicines, St. John’s wort, and cyclosporine (including transplant drugs) can force a dose change or a stop. Bring every pill, vitamin, and herbal to the pharmacist. Separate some P-gp substrate medicines by at least 4 hours.

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Access: how someone in need actually gets near this drug

Access by country (PDAC)

• United States: Commercial prescription after 26 Aug 2026 if you fit the label. EAP NCT07573215 is US/PR only; whether new patients still enter is unknown. Trial 302 is active but no longer taking new patients. RASolute 303 is no longer taking new patients at US sites (all 21 are listed as active, not recruiting).
• Canada: No licence. RASolute 303, the first-line trial, now lists 3 recruiting Canadian sites (see below). Oncologist may file SAP (company must still ship — unknown). First-line: ask your oncologist about referral to one of the 3 Canadian RASolute 303 sites in Toronto or Montreal. Cross-border US care is a medical/legal/financial plan, not a DIY import.
• EU/EEA: Not authorized. CHMP phased review started 7 Jul 2026; full MAA not submitted. Trial 302, which has sites in France, Germany, Italy and Spain, is active but no longer taking new patients. Compassionate-use / named-patient rules are national — ask the treating oncologist. A phased review is not a licence.
• United Kingdom: PDAC licence not found as of 2 Sep 2026. The 10 Jun 2026 UK note is pre-FDA, not a post-approval MHRA decision. RASolute 303 is recruiting for first-line. EAMS not found.
• Japan: Orbis observer, marketing authorization not found. Trial 302 is active but no longer taking new patients; trial 303 is recruiting.
• Australia: ARTG registration for this PDAC indication not found as of 2 Sep 2026. 303 recruiting. Check ARTG.
• Brazil, Taiwan: 303 recruiting (trial access). No marketing authorization found.
• Everywhere else: If your regulator has not authorized it, the realistic options are a recruiting 303 site you can actually reach, a US prescription if you can arrange US care, or a local compassionate programme if one exists. Do not buy unnamed RAS pills online.

If you are in the United States

• Commercial prescription is now the intended path. The FDA approved Rasonque on 26 August 2026. Ask a GI or pancreatic oncologist to prescribe it if you fit the label. Manufacturer medical information: 1-844-2-REVMED (1-844-273-8633).
• A US expanded-access protocol (NCT07573215) is listed as approved for marketing (updated 1 September 2026). Sites are in the United States and Puerto Rico only. Whether new patients are still enrolled after approval is unknown; your US oncologist can ask the sponsor. FDA Project Facilitate (for clinicians, investigational oncology access): 240-402-0004 or OncProjectFacilitate@fda.hhs.gov.
• RASolute 302 (NCT06625320) is not recruiting. Do not expect a slot there.
• RASolute 303 (NCT07491445), the first-line trial, is no longer taking new patients in the US: all 21 US sites are listed as active, not recruiting (ClinicalTrials.gov, checked 10 October 2026). It is still recruiting in other countries, including Canada.

Price, copay programs, and hospital formulary status: unknown from the label.

If you are in Canada

Be blunt with yourself and your team: this pill is not a Canadian pharmacy drug today.

1. Health Canada approval — not confirmed.
The FDA reviewed this under Project Orbis and named Health Canada as a collaborator. The FDA said partner applications may still be under review. That is not a confirmed Canadian filing and it is not “Health Canada has no filing.” A Notice of Compliance was not found. Indexed Drug Product Database pages did not show Rasonque or daraxonrasib. Until Health Canada issues an NOC and a DIN appears, Canadian public drug plans will not list it.

1. Clinical trials in Canada — one first-line trial is now recruiting. As of 10 October 2026, ClinicalTrials.gov lists no Canadian sites for:

• NCT06625320 (RASolute 302, active but no longer taking new patients)
• NCT07573215 (expanded access, US/Puerto Rico)

RASolute 303 (NCT07491445, first-line) now lists 3 Canadian sites as recruiting: Sunnybrook Research Institute and Princess Margaret Cancer Centre in Toronto, and the McGill University Department of Oncology Clinical Research Program in Montreal. BC Cancer is not listed. A recruiting site does not mean you qualify or that a place is free. The trial team decides. Ask your oncologist to check the record with you. Do not travel on a rumour.

3. Health Canada Special Access Programme (SAP) — possible on paper, not guaranteed in the cupboard.
A licensed Canadian practitioner can request an unapproved drug for a medical emergency when licensed options have failed, are unsuitable, or are unavailable. Metastatic pancreatic cancer can meet that bar. After FDA approval, Health Canada says it will consider expediting SAP review for a drug already authorized by the FDA.

SAP is not a mail-order service:

• Your oncologist (not you) faxes the SAP form to 613-941-3194, or calls 613-941-2108 in a critical emergency (24/7).
• Health Canada may authorize the request.
• The company still has to ship the drug. Health Canada cannot force a manufacturer to supply. Cost, if any, is set by the manufacturer — hospital, insurer, or family may be asked to pay.
• Whether Revolution Medicines will supply Rasonque through SAP after US approval is unknown from primary sources. Ask your oncologist to try, and to get a written yes or no from the company medical team (medinfo@revmed.com / 1-844-273-8633).

4. Care in the United States.
FDA-approved drug can be prescribed by a US-licensed physician. That usually means a US consult, US pharmacy, and out-of-pocket or US insurance costs. Immigration, travel while ill, and who follows your labs are practical barriers. This is a real path for some families and an impossible one for others. Do not delay local symptom control while you explore it.

1. First-line patients. If you have not started treatment for metastatic disease, RASolute 303 is the trial that is open, including at 3 sites in Canada. To join, you must give consent within 6 weeks of the metastatic diagnosis, so ask early. It randomizes to pill alone, pill plus gemcitabine/nab-paclitaxel, or chemo alone. You may get chemo only. Recruiting sites include Sunnybrook and Princess Margaret in Toronto and McGill in Montreal, plus hospitals in the UK, Japan, Australia, South Korea, Taiwan, Italy, Spain and other countries. The US sites, including Dana-Farber, Memorial Sloan Kettering, MD Anderson, Johns Hopkins and UCSF, are no longer taking new patients. Start with your Canadian oncologist and the sponsor contact above.

Other countries

RASolute 302 also has sites in France, Germany, Italy, Japan and Spain; it is active but no longer taking new patients. RASolute 303 is open in the UK, Japan, Australia, Taiwan, and Brazil. EMA was an Orbis observer, not listed as an approving agency on 26 August 2026. National approval outside the US: unknown.

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What to say to your doctor (bring this)

You can read this out:

“The FDA approved daraxonrasib (Rasonque) on 26 August 2026. The labelled indication is: adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. The trial is RASolute 302, NCT06625320, published in NEJM. Dose is 300 mg once daily. RAS testing is not required for the US indication; the trial still required RAS status to be documented (mutant or wild-type). That is not a labelling CDx.
In Canada it is not confirmed as approved. ClinicalTrials.gov lists no Canadian sites for 302 or the US expanded-access programme, but the first-line trial RASolute 303 now has 3 recruiting Canadian sites.
Can you: (1) confirm whether I fit the FDA label; (2) submit a Health Canada SAP request and ask Revolution Medicines in writing if they will supply; (3) if I have not had first-line treatment, check RASolute 303 (NCT07491445) for a site I could reach; (4) if we look at US care, name a US pancreatic oncologist who is already using the drug?
If we start it, I want a rash-prevention plan (steroid cream, moisturiser, sunscreen, consider doxycycline) and a mouth-care and diarrhea plan on day one.”

If your local oncologist has never heard of the drug, ask for referral to a high-volume pancreatic cancer clinic. In Canada that still does not create supply — it creates a doctor who knows how to file SAP and how to manage the rash.

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What this does not mean

• It is not a cure. Median survival in the trial was just over a year, not a lifetime.
• It is not approved to prevent pancreatic cancer, treat resectable disease, or replace first-line chemo in Canada or the US (first-line is still in RASolute 303).
• Trial 302 is active but no longer taking new patients, so it cannot enrol you.
• A news story about a Canadian centre “expecting” a trial is not a slot.

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Primary sources

1. FDA. FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma. 26 August 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma
2. FDA. FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer. 26 August 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-class-targeted-therapy-metastatic-pancreatic-cancer
3. RASONQUE (daraxonrasib) tablets. Prescribing Information and Medication Guide. Revolution Medicines, Inc. Issued 08/2026. https://www.revmed.com/wp-content/uploads/2026/08/rasonque-pi.pdf
4. O’Reilly EM, Wainberg ZA, Hendifar AE, et al. Daraxonrasib or Chemotherapy in Previously Treated Metastatic Pancreatic Cancer. N Engl J Med. 2026;395(4):325-337. Published online 31 May 2026. doi:10.1056/NEJMoa2605555. PMID: 42223072. https://www.nejm.org/doi/full/10.1056/NEJMoa2605555
5. ClinicalTrials.gov. NCT06625320 — RASolute 302. https://clinicaltrials.gov/study/NCT06625320
6. ClinicalTrials.gov. NCT07491445 — RASolute 303. https://clinicaltrials.gov/study/NCT07491445
7. ClinicalTrials.gov. NCT07573215 — Expanded access. https://clinicaltrials.gov/study/NCT07573215
8. FDA. FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug. 1 May 2026. https://www.fda.gov/news-events/press-announcements/fda-permits-expanded-access-investigational-pancreatic-cancer-drug
9. Health Canada. Request a drug through the Special Access Program. https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs.html
10. Health Canada. Drug Product Database (search). https://health-products.canada.ca/dpd-bdpp/search
11. Health Canada. Notice of Compliance Database. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/database.html

ASCO 2026 Abstract LBA5 (Wolpin BM et al., presented 31 May 2026) is the conference presentation of the same pivotal dataset; the citable journal report is the NEJM paper above. 12. EMA. EMA fast tracks review of a medicine for metastatic pancreatic cancer. 7 July 2026. https://www.ema.europa.eu/en/news/ema-fast-tracks-review-medicine-metastatic-pancreatic-cancer