Daraxonrasib (Rasonque by Revolution Medicines, Inc.), an inhibitor of the RAS GTPase family has been approved for the treatment of adults with metastatic pancreatic ductal adenocarcinoma (mPDAC) on 26 August 2026 by the FDA. Pancreatic ductal adenocarcinoma is the most common form of pancreatic cancer. Approval of daraxonrasib offers these patients a new treatment option. Tumour Treating Fields (TTFields) therapy by alternating electrical fields was earlier approved for locally advanced pancreatic cancer on 12 February 2026.
The approval of daraxonrasib was based on findings from a phase 3 clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma, daraxonrasib was found to improve median overall survival to 13.2 months compared to 6.7 months for standard chemotherapy.
RAS protein is the key driver of tumour growth in most patients with pancreatic adenocarcinoma. Daraxonrasib targets this. The recommended dose is 300 mg orally once daily until disease progression or unacceptable toxicity, and is approved for the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
Pancreatic adenocarcinoma constitutes about 3.2% of all cancer cases, however this accounts for a disproportionately high share of cancer deaths, due to late detection, aggressive disease course, and limited treatment options. Current treatment offers limited benefit for patients with previously treated metastatic pancreatic ductal adenocarcinoma (mPDAC). For such patients, treatment with daraxonrasib led to significantly longer overall survival and progression-free survival than chemotherapy.
For locally advanced pancreatic cancer, Tumour Treating Fields (TTFields) therapy by alternating electrical fields was approved by the FDA earlier on 12 February 2026. This was significant given clinical management of pancreatic cancer is challenging in view of poor prognosis and low survival rate.
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References:
- FDA News release. FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer. 26 August 2026. Available at https://www.fda.gov/news-events/press-announcements/fda-approves-first-class-targeted-therapy-metastatic-pancreatic-cancer
- FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma. Available at https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma
- O’Reilly E.M., et al 2026. Daraxonrasib or Chemotherapy in Previously Treated Metastatic Pancreatic Cancer. NEJM. 31 May 2026. DOI: https://doi.org/10.1056/NEJMoa2605555
- Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) (RASolute 302). https://clinicaltrials.gov/study/NCT06625320
- FDA News Release – FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer. Posted 12 February 2026. Available at https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-device-treat-pancreatic-cancer
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Related articles:
- Tumour Treating Fields (TTFields) approved for Pancreatic cancer (13 February 2026)
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