# FDA approves Rasonque for pancreatic cancer; lung cancer use > Live situation record from CLSTR: https://clstr.news/situations/biotech-breakthroughs-and-regulatory-milestones-in-hereditary-angioedema-and-pancreatic-cancer-thera > Updated: 2026-09-03T03:00:00.000Z. Sources: 292. Developments: 36. 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 or investigator-choice chemotherapy. This represents a 60% reduction in the risk of death and a doubling of median progression-free survival. The therapy is indicated for patients who have progressed after initial chemotherapy or are ineligible for multiagent systemic therapy. While approved in the U.S., the drug remains investigational elsewhere; the European Medicines Agency (EMA) has initiated a phased review to determine future availability in Europe and the Nordic regions. Beyond pancreatic cancer, clinical trial data published in the New England Journal of Medicine indicates that daraxonrasib shows promise in treating advanced non-small cell lung cancer (NSCLC) with RAS mutations. In a Phase 1/2 trial of patients previously treated with platinum-based chemotherapy and immunotherapy, researchers observed an objective response rate of 42% in a specific cohort. The therapy is currently advancing through the Phase 3 RASolve 301 trial for this indication. ## Claims - In the RASolute 302 trial, patients receiving Rasonque had a median overall survival of 13.2 months, compared to 6.7 months for those receiving chemotherapy. (corroborated by 45 sources) - The drug will be marketed commercially under the name Rasonque. (corroborated by 40 sources) - Rasonque is a once-daily oral tablet. (corroborated by 30 sources) - The drug targets the RAS protein, which is mutated in approximately 90% of pancreatic cancer cases. (corroborated by 22 sources) - Daraxonrasib targets the mutated KRAS protein to inhibit tumor growth. (corroborated by 20 sources) - The FDA approved daraxonrasib (Rasonque) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic療法. (corroborated by 15 sources) - Common adverse reactions to the drug include rash, diarrhea, and stomatitis. (corroborated by 9 sources) - The drug is a multi-selective RAS inhibitor designed to block the RAS protein responsible for tumor proliferation. (corroborated by 9 sources) ## Timeline ### 2026-09-03: Daraxonrasib shows clinical promise for RAS-mutant lung cancer Daraxonrasib, an oral RAS inhibitor, has shown a 42% response rate in clinical trials for patients with advanced, treatment-resistant non-small cell lung cancer. 6 sources. https://clstr.news/cluster/daraxonrasib-shows-clinical-promise-for-ras-mutant-lung-cancer ### 2026-08-31: 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. 7 sources. https://clstr.news/cluster/fda-approves-first-in-class-targeted-therapy-for-pancreatic-cancer ### 2026-08-28: 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. 11 sources. https://clstr.news/cluster/fda-approves-daraxonrasib-for-metastatic-pancreatic-cancer-1 ### 2026-08-28: 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. 5 sources. https://clstr.news/cluster/fda-approves-first-oral-drug-for-advanced-pancreatic-cancer ### 2026-08-26: 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. 156 sources. https://clstr.news/cluster/fda-approves-daraxonrasib-pill-to-treat-metastatic-pancreatic-cancer ### 2026-08-13: 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. 3 sources. https://clstr.news/cluster/daraxonrasib-doubles-survival-rates-in-pancreatic-cancer-trials-1 ### 2026-07-31: 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. 4 sources. https://clstr.news/cluster/pancreatic-cancer-advances-vaccine-shows-safety-and-drug-doubles-survival ### 2026-07-25: 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. 2 sources. https://clstr.news/cluster/daraxonrasib-pill-doubles-median-survival-in-metastatic-pancreatic-cancer ### 2026-07-14: 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. 3 sources. https://clstr.news/cluster/kras-inhibitor-daraxonrasib-shows-early-promise-for-pancreatic-and-appendix-cancers ### 2026-07-07: 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. 2 sources. https://clstr.news/cluster/european-medicines-agency-launches-accelerated-review-of-revolution-medicines-pancreatic-cancer-drug ### 2026-06-22: 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. 3 sources. https://clstr.news/cluster/dualcheckpoint-melanoma-therapy-and-krastargeted-pancreatic-drug-show-promising-trial-results ### 2026-06-21: 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 2 sources. https://clstr.news/cluster/revolution-medicines-rejects-sale-prioritizes-independent-rasinhibitor-development ### 2026-06-13: 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 3 sources. https://clstr.news/cluster/asco-unveils-promising-new-cancer-treatments ### 2026-06-10: 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. 3 sources. https://clstr.news/cluster/daraxonrasib-pill-shows-promise-against-metastatic-pancreatic-cancer ### 2026-06-09: 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. 2 sources. https://clstr.news/cluster/daraxonrasib-cancer-drug-doubles-pancreatic-cancer-survival-existing-cancer-meds-show-promise-for-al ### 2026-06-06: 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. 2 sources. https://clstr.news/cluster/experimental-cancer-drugs-amivantamab-and-daraxonrasib-show-strong-tumor-reductions ### 2026-06-06: 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. 3 sources. https://clstr.news/cluster/revolution-medicines-pancreatic-cancer-pill-doubles-survival-as-germany-launches-new-oncology-nursin ### 2026-06-05: 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‑ 6 sources. https://clstr.news/cluster/daraxonrasib-shows-survival-boost-for-advanced-pancreatic-cancer-patients ### 2026-06-05: 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 7 sources. https://clstr.news/cluster/daraxonrasib-drug-doubles-survival-for-pancreatic-cancer-patients ### 2026-06-05: 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 2 sources. https://clstr.news/cluster/revolution-medicines-biotech-stock-soars-near-100-on-strong-cancer-trial-results ### 2026-06-04: 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 6 sources. https://clstr.news/cluster/asco-2026-shows-promising-new-drugs-for-pancreatic-cancer-and-melanoma ### 2026-06-03: 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. 2 sources. https://clstr.news/cluster/pancreatic-cancer-patients-face-limited-trial-access-in-uk-and-canada ### 2026-06-03: 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. 2 sources. https://clstr.news/cluster/pancreatic-cancer-drug-daraxonrasib-shows-double-survival-canada-to-launch-trials ### 2026-06-02: 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. 3 sources. https://clstr.news/cluster/daraxonrasib-pill-doubles-survival-for-metastatic-pancreatic-cancer-patients ### 2026-06-02: 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 2 sources. https://clstr.news/cluster/kras-inhibitor-daraxonrasib-doubles-pancreatic-cancer-survival-blood-test-flags-breast-cancer-resist ### 2026-06-02: 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. 2 sources. https://clstr.news/cluster/daraxonrasib-drug-shows-doubled-survival-for-pancreatic-cancer-patients ### 2026-05-31: 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. 3 sources. https://clstr.news/cluster/revolution-medicines-drug-daraxonrasib-doubles-pancreatic-cancer-survival ### 2026-05-31: 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. 3 sources. https://clstr.news/cluster/new-pancreatic-cancer-drug-daraxonrasib-and-glp1-obesity-meds-show-promise-against-metastasis ### 2026-05-31: 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 55 sources. https://clstr.news/cluster/moderna-and-mercks-melanoma-vaccine-halves-recurrence-risk ### 2026-05-26: 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. 2 sources. https://clstr.news/cluster/pancreatic-cancer-breakthroughs-kras-inhibitor-daraxonrasib-and-vitamin-d-analog-improve-outcomes ### 2026-05-16: 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. 2 sources. https://clstr.news/cluster/pancreatic-cancer-drug-daraxonrasib-shows-promise-in-early-trial ### 2026-05-14: 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. 5 sources. https://clstr.news/cluster/kras-inhibitor-daraxonrasib-extends-pancreatic-cancer-survival-while-glp-1-drugs-linked-to-breast-ca ### 2026-05-12: 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. 4 sources. https://clstr.news/cluster/daraxonrasib-kras-inhibitor-extends-survival-in-pancreatic-cancer-patients ### 2026-05-07: 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. 3 sources. https://clstr.news/cluster/fda-approves-daraxonrasib-for-pancreatic-cancer-as-vitamin-c-therapy-stays-debated ### 2026-05-07: 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. 2 sources. https://clstr.news/cluster/daraxonrasib-boosts-survival-in-metastatic-pancreatic-cancer ### 2026-05-07: Pancreatic Cancer Breakthroughs: Mitochondrial Inflammation Target and Survival‑Doubling Drug New mitochondrial inflammation target and KRAS inhibitor daraxonrasib nearly double survival in pancreatic cancer. 2 sources. https://clstr.news/cluster/pancreatic-cancer-breakthroughs-mitochondrial-inflammation-target-and-survivaldoubling-drug --- Cite as: FDA approves Rasonque for pancreatic cancer; lung cancer use. CLSTR, https://clstr.news/situations/biotech-breakthroughs-and-regulatory-milestones-in-hereditary-angioedema-and-pancreatic-cancer-thera