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44 clusters · 321 sources · 166 days · First seen · Last updated

FDA approves Rasonque; EMA recommends for pancreatic cancer

Overview

On 26 August 2026, the U.S. Food and Drug Administration (FDA) granted expedited approval to daraxonrasib, marketed as Rasonque, for treating adults with metastatic pancreatic ductal adenocarcinoma (PDAC). Developed by Revolution Medicines, this once-daily oral pill is the first targeted therapy approved to inhibit the RAS protein, a molecular driver present in approximately 90% to 95% of pancreatic cancer cases.

The approval follows results from the Phase III RASolute 302 trial, which showed that patients receiving Rasonque achieved a median overall survival of 13.2 months, compared to 6.7 months for those receiving standard chemotherapy. Clinical data also indicated a 60% reduction in the risk of death and an objective response rate of 30%.

Global efforts to secure access continue. In Japan, patients and families have launched an online petition for “conditional early approval” of the drug, which has already been designated as an orphan drug by the Ministry of Health, Labour and Welfare. In Europe, the European Medicines Agency (EMA) recommended the approval of Rasonque for adults with metastatic pancreatic cancer who have undergone at least one prior treatment. This recommendation follows an accelerated assessment procedure.

On 18 October 2026, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for didaraxonrasib, an oral therapy for adults with metastatic pancreatic adenocarcinoma who have previously undergone chemotherapy. Evaluated under the Cancer Medicines Pathfinder pilot program, the drug aims to address high unmet medical needs. Following this opinion, the medication must receive formal marketing authorization from the European Commission before national authorities, such as Italy’s AIFA, can negotiate pricing and reimbursement.

Entities

daraxonrasib · FDA · Revolution Medicines · European Medicines Agency · Rasonque

Claims

What the coverage asserts, and how many sources carry each claim.

Timeline

  1. [HEALTH] 2 sources
    Pancreatic cancer: New research and treatment developments in Greece

    Greece is participating in the European SHIELD program for early pancreatic cancer detection, alongside advancements in treatment via the RAS pathway inhibitor daraxonrasib.

  2. [HEALTH] 5 sources
    EMA recommends authorization for two new oral medications

    The EMA's CHMP has recommended authorization for two new oral drugs: Foundayo for obesity and type 2 diabetes, and didaraxonrasib for metastatic pancreatic adenocarcinoma.

  3. [HEALTH] 18 sources
    EMA recommends approval of Daraxonrasib for metastatic pancreatic cancer

    The EMA has recommended approving daraxonrasib (Rasonque) for metastatic pancreatic cancer, showing a median survival of 12.4 months in clinical trials compared to 6.7 months with chemotherapy.

  4. [HEALTH] 2 sources
    Japan patients petition for early approval of pancreatic cancer drug

    Japanese pancreatic cancer patients are petitioning for the rapid approval of darlaxonrasib, a drug that doubled survival rates in U.S. clinical trials, to provide new treatment options in Japan.

  5. [HEALTH] 4 sources
    FDA approves daraxonrasib for metastatic pancreatic cancer

    The FDA has approved the oral drug daraxonrasib for metastatic pancreatic cancer, nearly doubling median survival rates in clinical trials. Additionally, oral risdiplam is improving autonomy for SMA patients.

  6. [HEALTH] 2 sources
    Angelica Pasculli seeks access to US cancer drug unavailable in Europe

    A mother battling pancreatic cancer is appealing for access to daraxonrasib, a drug available in the US but not in Europe due to high costs and regulatory negotiations.

  7. [HEALTH] 8 sources
    Max Parisi seeks FDA-approved pancreatic cancer drug in the U.S

    Radio host Max Parisi is traveling to the U.S. to access daraxonrasib, an FDA-approved drug for pancreatic cancer, following a terminal diagnosis in Italy.

  8. [HEALTH] 2 sources
    Pancreatic cancer research advances through cell communication studies and new drug access

    New research and experimental therapies are targeting pancreatic cancer, including discoveries regarding cell communication in Argentina and access to the investigational drug Daraxonrasib in the US.

  9. [HEALTH] 5 sources
    Daraxonrasib approved by FDA for metastatic pancreatic cancer

    The FDA has approved daraxonrasib (Rasonque) for metastatic pancreatic cancer, nearly doubling median survival to 13.2 months in clinical trials by targeting the RAS protein mechanism.

  10. [HEALTH] 7 sources
    FDA approves Rasonque for metastatic pancreatic cancer

    The FDA has approved Rasonque (daraxonrasib), the first RAS-targeted pill for metastatic pancreatic cancer, which nearly doubled median survival rates compared to standard chemotherapy.

  11. [HEALTH] 11 sources
    FDA approves daraxonrasib for metastatic pancreatic cancer

    The FDA has approved daraxonrasib (Rasonque), a once-daily oral RAS inhibitor, for metastatic pancreatic cancer, nearly doubling median survival to 13.2 months in clinical trials.

  12. [HEALTH] 5 sources
    FDA approves first oral drug for advanced pancreatic cancer

    The FDA has approved daraksonrasib, the first oral pill for advanced pancreatic cancer, which nearly doubled median survival time in clinical trials compared to standard chemotherapy.

  13. [HEALTH] 156 sources
    FDA approves Rasonque for metastatic pancreatic cancer

    The FDA has approved Rasonque (daraxonrasib), a first-of-its-kind oral RAS inhibitor for metastatic pancreatic cancer, which nearly doubled median survival rates in clinical trials.

  14. [HEALTH] 3 sources
    Daraxonrasib doubles survival rates in pancreatic cancer trials

    Experimental drug daraxonrasib nearly doubles survival rates for metastatic pancreatic cancer patients by targeting KRAS mutations, according to Phase 3 trial results.

  15. [HEALTH] 4 sources
    Pancreatic Cancer Advances: Vaccine Shows Safety and Drug Doubles Survival

    A KRAS‑targeting vaccine proved safe and reduced cysts, while the drug daraxonrasib doubled median survival for metastatic pancreatic cancer patients.

  16. [HEALTH] 2 sources
    Daraxonrasib pill doubles median survival in metastatic pancreatic cancer

    Trial of oral drug daraxonrasib nearly doubles survival for metastatic pancreatic cancer patients, but the drug remains under regulatory review.

  17. [HEALTH] 3 sources
    KRAS inhibitor daraxonrasib shows early promise for pancreatic and appendix cancers

    Pan‑RAS inhibitor daraxonrasib and other KRAS‑targeted drugs show early anti‑tumor activity in pancreatic and rare appendix cancers, prompting larger trials.

  18. [HEALTH] 2 sources
    European Medicines Agency launches accelerated review of Revolution Medicines' pancreatic cancer drug daraxonrasib

    The EMA has started an accelerated rolling review of Revolution Medicines' pancreatic cancer drug daraxonrasib after phase‑3 trial results showed it nearly doubled median survival versus chemotherapy.

  19. [HEALTH] 3 sources
    Dual‑Checkpoint Melanoma Therapy and KRAS‑Targeted Pancreatic Drug Show Promising Trial Results

    Phase III trials show a dual‑checkpoint immunotherapy cuts melanoma progression by 42% and a KRAS inhibitor doubles survival in advanced pancreatic cancer, prompting regulatory reviews.

  20. [BUSINESS] 2 sources
    Revolution Medicines Rejects Sale, Prioritizes Independent RAS‑Inhibitor Development

    Revolution Medicines says a sale is not a priority and will continue independent development of its RAS‑inhibitor cancer drugs, including RMC‑6236, targeting KRAS mutations, with trial data expected through 202

  21. [HEALTH] 3 sources
    ASCO Unveils Promising New Cancer Treatments

    At ASCO, a bispecific antibody shrank tumors in 47 % of patients and the new PI3K/AKT/mTOR inhibitor gedatolisib more than quadrupled progression‑free survival for metastatic hormone‑receptor‑positive breast‑c­

  22. [HEALTH] 3 sources
    Daraxonrasib pill shows promise against metastatic pancreatic cancer

    Daraxonrasib, an oral KRAS‑targeting drug, showed in Phase III trials at ASCO 2026 that 9‑10 % of patients with metastatic pancreatic cancer survived beyond five years, marking a notable advance.

  23. [HEALTH] 2 sources
    Daraxonrasib cancer drug doubles pancreatic cancer survival; existing cancer meds show promise for Alzheimer’s

    Daraxonrasib doubled pancreatic cancer survival in trials, while approved cancer drugs letrozole and irinotecan reversed Alzheimer’s pathology in mice.

  24. [HEALTH] 2 sources
    Experimental cancer drugs amivantamab and daraxonrasib show strong trial outcomes

    Amivantamab cuts head/neck tumours in 43% of patients, while daraxonrasib doubles survival for advanced pancreatic cancer; results presented at ASCO and under FDA review.

  25. [HEALTH] 3 sources
    Revolution Medicines' Pancreatic Cancer Pill Doubles Survival as Germany Launches New Oncology Nursing Service

    Revolution Medicines' experimental pancreatic‑cancer pill doubled survival and gained German regulator support, while Leipzig's UCCL launched an oncology nursing counseling service to aid patients.

  26. [HEALTH] 6 sources
    Daraxonrasib Doubles Survival in Metastatic Pancreatic Cancer Trial

    Phase 3 data show daraxonrasib nearly doubles median survival for metastatic pancreatic cancer to 13.2 months versus 6.7 months, prompting FDA‑authorized expanded access but with supply and administrative bott‑

  27. [HEALTH] 7 sources
    New Pancreatic Cancer Pill Doubles Survival, Blood Test for Colon Cancer Sparks Debate, FDA Fast‑Track Granted to Lung‑c

    A new pancreatic‑cancer pill doubles survival, a blood test for colorectal screening sparks caution, and the FDA grants fast‑track status to a lung‑cancer program, alongside several recent cancer‑drug approvals

  28. [BUSINESS] 2 sources
    Revolution Medicines biotech stock jumps 97% as RAS‑targeted drug shows promise

    Revolution Medicines stock is up 97% this year after its RAS‑targeted drug daraxonrasib showed a survival benefit in a pancreatic cancer trial, but the cash‑burning biotech still faces high valuation and no bre

  29. [HEALTH] 6 sources
    New Cancer Therapies Show Promise at ASCO 2026 Conference

    ASCO 2026 unveiled promising data: daraxonrasib doubled survival in metastatic pancreatic cancer, amivantamab cleared tumors in head‑and‑neck cases, an mRNA melanoma vaccine cut recurrence risk 49%, and GSK and

  30. [HEALTH] 2 sources
    Pancreatic cancer patients face limited trial access in UK and Canada

    UK patients receive clinical trial offers at only 12%, prompting calls for faster trial access, while Canada prepares trials of daraxonrasib, a pill that doubled pancreatic cancer survival in a phase‑3 study.

  31. [HEALTH] 2 sources
    Pancreatic Cancer Drug Daraxonrasib Shows Double Survival, Canada to Launch Trials

    Canadian oncologist Dr. Jennifer Knox says experimental drug daraxonrasib doubled pancreatic cancer survival in a US trial and hopes to start Canadian trials soon.

  32. [HEALTH] 3 sources
    Daraxonrasib pill doubles survival for metastatic pancreatic cancer patients

    Phase‑3 trial shows oral KRAS‑inhibitor daraxonrasib nearly doubles survival for metastatic pancreatic cancer, prompting standing ovations at ASCO and raising hopes of a new treatment standard.

  33. [HEALTH] 2 sources
    KRAS inhibitor Daraxonrasib doubles pancreatic cancer survival; blood test flags breast cancer resistance early

    Daraxonrasib, an oral KRAS inhibitor, doubled median survival in metastatic pancreatic cancer, while a liquid‑biopsy blood test in the SERENA‑6 trial detected breast cancer drug resistance months early, both at

  34. [HEALTH] 2 sources
    Daraxonrasib drug shows doubled survival for pancreatic cancer patients

    Phase‑3 trial shows oral KRAS‑targeting drug daraxonrasib nearly doubles median survival for metastatic pancreatic cancer, with modest side effects and tumor shrinkage in many patients.

  35. [HEALTH] 3 sources
    Revolution Medicines' drug daraxonrasib doubles pancreatic cancer survival

    Experimental drug daraxonrasib doubles survival for advanced pancreatic cancer, cuts death risk by 60% and gains FDA expanded access; further trials needed.

  36. [HEALTH] 3 sources
    New pancreatic cancer drug daraxonrasib and GLP‑1 obesity meds show promise against metastasis

    Daraxonrasib nearly doubled survival in metastatic pancreatic cancer, while GLP‑1 obesity drugs cut metastasis risk by up to 50 % in several cancers, researchers reported at the ASCO Chicago meeting.

  37. [HEALTH] 55 sources
    ASCO 2026 showcases multiple cancer therapy breakthroughs

    ASCO 2026 highlighted several cancer breakthroughs: a melanoma mRNA vaccine cut recurrence by 49%, amivantamab shrank head‑and‑neck tumours, a combo immunotherapy slowed liver cancer progression by 30%, and dar

  38. [HEALTH] 2 sources
    Pancreatic Cancer Breakthroughs: KRAS inhibitor daraxonrasib and Vitamin D analog improve outcomes

    KRAS inhibitor daraxonrasib doubled median survival in advanced pancreatic cancer, while vitamin D analog paricalcitol reprogrammed tumor stroma to enhance chemotherapy response and immune infiltration.

  39. [HEALTH] 2 sources
    Pancreatic Cancer Drug Daraxonrasib Shows Promise in Early Trial

    Oral drug daraxonrasib targets KRAS mutations in advanced pancreatic cancer, showing 35% response and 13‑month median survival in early trial.

  40. [HEALTH] 5 sources
    KRAS inhibitor daraxonrasib extends pancreatic cancer survival, while GLP-1 drugs linked to breast cancer benefits

    Daraxonrasib extends life for pancreatic cancer patients; GLP‑1 drugs associated with lower breast cancer mortality and recurrence.

  41. [HEALTH] 4 sources
    Daraxonrasib KRAS inhibitor extends survival in pancreatic cancer patients

    Daraxonrasib, a KRAS‑targeting drug, may win FDA approval after boosting median survival to over 13 months for pancreatic cancer patients.

  42. [HEALTH] 3 sources
    FDA approves daraxonrasib for pancreatic cancer as vitamin C therapy stays debated

    FDA fast‑tracks daraxonrasib for pancreatic cancer while high‑dose IV vitamin C remains unproven.

  43. [HEALTH] 2 sources
    Daraxonrasib Boosts Survival in Metastatic Pancreatic Cancer

    Daraxonrasib more than doubled median overall survival to 13.2 months versus 6.7 months in a Phase 3 trial of previously treated metastatic pancreatic cancer.

  44. [HEALTH] 2 sources
    Pancreatic Cancer Breakthroughs: Mitochondrial Inflammation Target and Survival‑Doubling Drug

    New mitochondrial inflammation target and KRAS inhibitor daraxonrasib nearly double survival in pancreatic cancer.

Sources

2001online.com · 20minutos.es · 24-ore.com · aacr.org · abc13.com · abc7.com · actualidad.es · actualidad.rt.com · actusante.net · ad-hoc-news.de · adnKronos.com · afamily.vn · agriniosite.gr · allsides.com · almakos.com · almouwatin.com · alreporter.com · americanwirenews.com · archynewsy.com · arroyodiario.com.ar · arynews.tv · asaaseradio.com · aydinses.com · bangordailynews.com · baolaocai.vn · bigodino.it · bild.de · bolnews.com · brasilemfolhas.com.br · buffalohealthyliving.com · ca.sports.yahoo.com · cadenaoh.com.ar · cafebiz.vn · canal12melo.com · canaledieci.it · canaln.pe · cancernetwork.com · cbsnews.com · ch23.com · chicago.suntimes.com · china5e.com · chip.com.tr · cinquecolonne.it · ckom.com · clicmedicina.it · clinica.bg · clinicalomics.com · codirp.it

This summary has been updated 15 times: see revision history