daraxonrasib
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At the ESMO Congress, UCLA researchers presented a new subgroup analysis of the phase 3 RASolute 302 trial, showing that the oral RAS inhibitor daraxonrasib (RASONQUE) extended median overall survival in advanced pancreatic cancer from 6.7 months with standard chemotherapy to 13.2 months. The benefit held across all RAS mutation subgroups, including patients with no detected mutation, and across different chemotherapy control regimens. The FDA approved the drug in August 2026 for metastatic pancreatic adenocarcinoma after at least one prior line of systemic therapy.
Excerpted from medicalxpress.com
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- medicalxpress.comPickESMO: New analysis reinforces survival benefits of targeted therapy for advanced pancreatic cancer
At the ESMO Congress, UCLA researchers presented a new subgroup analysis of the phase 3 RASolute 302 trial, showing that the oral RAS inhibitor daraxonrasib (RASONQUE) extended median overall survival in advanced pancreatic cancer from 6.7 months with standard chemotherapy to 13.2 months. The benefit held across all RAS mutation subgroups, including patients with no detected mutation, and across different chemotherapy control regimens. The FDA approved the drug in August 2026 for metastatic pancreatic adenocarcinoma after at least one prior line of systemic therapy.
- mp.weixin.qq.comPickImprecise Label in the Precision Medicine Era: FDA Approval of Daraxonrasib
The FDA has approved the pan-RAS inhibitor daraxonrasib for previously treated metastatic pancreatic adenocarcinoma. The RASolute 302 trial showed a median overall survival of 13.2 months (HR 0.40), but the label's extension to patients "not suitable for multi-drug systemic therapy" has drawn controversy.
- nejm.orgDaraxonrasib in Previously Treated Metastatic Pancreatic Cancer
NEJM published a brief piece on daraxonrasib in previously treated metastatic pancreatic cancer on October 22, 2026 (Volume 395, Issue 16, pp. 1661-1662). The material provided contains only the journal citation and no specific trial results or conclusions.
- mp.weixin.qq.comPickRasonque (daraxonrasib) wins FDA approval in 40 days under Commissioner's National Priority Voucher
Rasonque (daraxonrasib) received FDA approval for second-line metastatic pancreatic cancer just 40 days after formal acceptance, 203 days ahead of its PDUFA goal date. The review used the Commissioner's National Priority Voucher (CNPV), an accelerated pilot mechanism FDA launched in June 2025 that breaks the traditional review framework used for decades.
- biocentury.comPickEMA’s CHMP backs RevMed’s first-in-class pancreatic cancer therapy
At its October meeting, EMA's Committee for Medicinal Products for Human Use (CHMP) recommended Rasonque (daraxonrasib), a first-in-class pan-RAS(ON) inhibitor from Revolution Medicines, for patients with metastatic pancreatic ductal adenocarcinoma who have received at least one prior line of therapy.
- mp.weixin.qq.comCHMP Backs EU Approval of Revolution Medicines' Daraxonrasib for Metastatic Pancreatic Cancer
The EU's CHMP has issued a positive opinion recommending approval of Revolution Medicines' RASONQUE (daraxonrasib, RMC-6236) for metastatic pancreatic ductal adenocarcinoma. If the European Commission follows the recommendation, daraxonrasib would be approved across the EU for this indication. The opinion is dated 16 October 2026.
- ema.europa.euPickMeeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026
The EMA's CHMP recommended six new medicines at its October 2026 meeting, including Rasonque (daraxonrasib) for previously treated metastatic pancreatic adenocarcinoma and Foundayo (orforglipron), a once-daily oral GLP-1 receptor agonist for weight management and type 2 diabetes in adults. It also backed Yuviwel (navepegritide) for achondroplasia in children, biosimilars of ranibizumab and filgrastim, and Kizfizo (temozolomide) for glioblastoma and malignant glioma. The committee confirmed refusal of Yartemlea (narsoplimab) after re-examination, and companies withdrew indication-extension applications for Ibrance and Truqap.
- mp.weixin.qq.comVS-7375 posts 67% six-month progression-free survival in metastatic pancreatic cancer as daraxonrasib comparison sharpens
Verastem reported early data for its KRAS-targeted drug VS-7375 in metastatic pancreatic ductal adenocarcinoma: among 22 evaluable patients at 900 mg once daily, 16 remained on treatment at month 6, 6-month progression-free survival was 67% and overall survival 80%. Confirmed objective response rate was 41% (9/22), including 50% (4/8) in second-line patients. The numbers invite comparison with Revolution Medicines' daraxonrasib (RMC-6236), approved as RASONQUE on August 26, 2026, after FDA-disclosed data showed weak performance in a large subgroup that VS-7375's population resembles.
- mp.weixin.qq.comPickBroad-Spectrum RAS Inhibitor Daraxonrasib Wins FDA Approval in Metastatic Pancreatic Cancer
The broad-spectrum RAS inhibitor daraxonrasib received FDA approval on August 26 for metastatic pancreatic cancer in adults who have received at least one prior systemic therapy or are not suitable for multi-drug combination systemic therapy. Unlike KRAS G12C inhibitors, it covers mutations including G12V, G12D, G13 and Q61, and the article also notes strong efficacy in lung cancer.
- ema.europa.euPickEMA recommends authorisation of Rasonque for metastatic pancreatic cancer
The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended EU approval of the oral RAS inhibitor Rasonque (daraxonrasib) for adults with previously treated metastatic pancreatic adenocarcinoma. The applicant is Revolution Medicines. In a phase 3 study of 500 patients, 92% of whom had RAS G12 mutations, Rasonque gave a median overall survival of 12.4 months versus 6.7 months with chemotherapy, and median progression-free survival of 7.2 versus 3.6 months.
- nature.comPickRevMed’s pancreatic cancer drug first
The FDA in August approved Revolution Medicines' RAS inhibitor Rasonque (daraxonrasib) for metastatic pancreatic ductal adenocarcinoma, making it the first RAS-targeting drug for this indication.
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