CHMP Recommends Approval of Rasonque for Metastatic Pancreatic Cancer
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At its October 2026 meeting, the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Rasonque (daraxonrasib), a first-in-class pan-RAS(ON) inhibitor developed by Revolution Medicines. The recommendation covers patients with metastatic pancreatic ductal adenocarcinoma who have received at least one prior line of therapy. The CHMP opinion is a regulatory step toward European Commission approval; a final marketing authorization decision remains outstanding.
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Developments
- Oct 15 21:30 · 5 reportsCHMP backs Revolution Medicines' Rasonque for pancreatic cancerema.europa.eu · EMA recommends authorisation of Rasonque for metastatic pancreatic cancer
- Oct 1 08:00 · 1 reportDaraxonrasib approval spotlights pancreatic cancer interceptionnature.com · Can pancreatic cancer be stopped in its tracks? Radical tactic raises hopes
- Aug 26 23:31 · 7 reportsFDA approves first-in-class RAS inhibitor daraxonrasibfiercebiotech.com · FDA greenlights Revolution Medicines' pancreatic cancer gamechanger
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- 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.
- 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.
- statnews.comSTAT+: RevMed’s pancreatic cancer drug nears European approval
Revolution Medicines' pancreatic cancer drug is close to approval in Europe, according to STAT reporting. The drug, developed by the company covered by STAT's Europe correspondent, is moving toward a European regulatory decision for pancreatic cancer. Details of the review and the timeline are available to STAT+ subscribers.
- 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.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.
- biospace.comAnalysts eye RevMed’s pancreatic cancer launch, Merck’s data blitz for Q3 earnings
Revolution Medicines reports its first launch numbers for Rasonque, its FDA-approved pancreatic cancer medicine, in Q3 earnings; Truist Securities expects about $14 million in initial sales, below the $20 million consensus. Truist raised its 2026 forecast for the drug from $102 million to $113 million and has projected $13.8 billion in peak revenue, with a possible first-line expansion supporting $2.3 billion by 2028. Investors await launch details on the upcoming call, with Johnson & Johnson opening earnings season on Oct. 13.
- jamanetwork.comPickFDA Approves New Treatment for Advanced Pancreatic Cancer
The FDA has approved a first-in-class therapy for patients with metastatic pancreatic cancer. The original brief gives no specific drug name, mechanism of action, or trial data; consult the original article for details.
- biospace.comPickRevMed's Rasonque gets a subtype data asterisk, but analysts remain bullish
FDA review documents show that Revolution Medicines' RAS inhibitor Rasonque, approved early for pancreatic adenocarcinoma, performed unevenly across KRAS mutation subtypes in the Phase 3 RASolute 302 trial. Overall ORR was 33%, but patients with G12V mutations reached 50%, G12D patients 24%, and the small G12R cohort just 7%, below the chemotherapy control. Analysts at Leerink and Truist called the gap exploratory and still expect a record launch, with Truist projecting $2.3 billion in sales by 2028 if the drug moves into first-line disease.
- 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.
- mp.weixin.qq.comPickFDA Approves Revolution Medicines' Daraxonrasib for Metastatic Pancreatic Cancer
On August 26, 2026, the FDA approved daraxonrasib (brand name RASONQUE), developed by Revolution Medicines, for adults with metastatic pancreatic ductal adenocarcinoma who have received at least one prior systemic therapy or are unsuitable for multi-drug combination systemic therapy. It is the first FDA-approved RAS(ON) inhibitor worldwide, extending direct RAS inhibition beyond a single mutation subtype to a broader molecular population.
- nature.comCan pancreatic cancer be stopped in its tracks? Radical tactic raises hopes
The FDA's August approval of the pancreatic cancer drug daraxonrasib (Rasonque) has drawn attention to cancer interception, treating precancerous lesions before they turn malignant, in pancreatic cancer. At the AACR meeting, Simeone said combining early detection with interception could raise five-year survival from 13.7% to 50%; her PRECEDE study has enrolled 12,000 people, with more than 50 diagnosed pancreatic cancers, mostly early-stage.
- mp.weixin.qq.comPickFDA Approves New Drug That Extends Survival in Pancreatic Cancer
The FDA has approved a new drug for pancreatic cancer that reportedly extends survival in patients. The approval was reported by Scientific American on August 26 and relayed by Chinese industry media on August 29. No drug name, trial details or dosing information were given in the report.
- fiercebiotech.comPickFDA greenlights Revolution Medicines' pancreatic cancer gamechanger
FDA has approved Revolution Medicines' Ras inhibitor daraxonrasib for metastatic pancreatic cancer. The approval is based on clinical data that drew a standing ovation at the American Society of Clinical Oncology (ASCO) annual meeting in May.
- FiercePharmaPickFDA greenlights Revolution Medicines' pancreatic cancer gamechanger
The FDA has approved Revolution Medicines' Ras inhibitor daraxonrasib for metastatic pancreatic cancer. The decision follows data presented at the American Society of Clinical Oncology meeting in May. Daraxonrasib targets Ras in a disease setting with limited options.
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