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On August 26, 2026, the FDA approved Revolution Medicines' Rasonque (daraxonrasib), an oral pan-RAS inhibitor, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not suited to multi-drug treatment. It is the first broadly active RAS-targeted therapy to reach market, attacking a genetic driver in a disease where more than 90% of patients carry KRAS mutations — 44 years after RAS was identified as the first human oncogene. In the supporting Phase 3 trial, median overall survival was 13.2 months versus 6.7 on chemotherapy. Reviewed under the commissioner's national priority voucher program, it was approved 40 days after submission. WAC is $39,800 per 30-day supply. A larger randomized NSCLC study is underway after tumor shrinkage in over 30% of patients in a small trial.
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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.
- 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
EMA's human medicines committee (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. A phase 3 study enrolled 500 patients, 92% with RAS G12 mutations; median overall survival was 12.4 months with Rasonque versus 6.7 months with chemotherapy, and median progression-free survival was 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-class 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.
- fda.govOncology (Cancer)/Hematologic Malignancies Approval Notifications
The FDA issued a run of oncology and hematology approvals from July 31 to October 2, 2026. They include pirtobrutinib (Jaypirca, Eli Lilly) for previously untreated CLL or SLL without 17p deletion on October 2, belzutifan plus lenvatinib for advanced clear-cell renal cell carcinoma on September 24, lirafugratinib (Lyrfigtu, Elevar) for FGFR2-rearranged cholangiocarcinoma on September 23, imlunestrant plus abemaciclib for ESR1-mutated breast cancer on September 18, and daraxonrasib (RASONQUE, Revolution Medicines) for metastatic pancreatic adenocarcinoma on August 26. Accelerated approvals in the batch cover sevabertinib for HER2-mutated NSCLC, camizestrant for ESR1-mutated breast cancer, iberdomide for multiple myeloma, and vusolimogene oderparepvec plus nivolumab for melanoma.
- aacrjournals.orgctDNA Profiling Identifies Daraxonrasib Resistance Mechanisms
- 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.
- aacrjournals.orgPan-RAS Inhibitor Shows Activity in Advanced Lung Cancer
The pan-RAS inhibitor daraxonrasib shrank tumors in more than 30% of patients with previously treated RAS-mutant non-small cell lung cancer. The drug recently earned approval in pancreatic cancer, and these findings support an ongoing phase III trial in lung cancer.
- BioCenturyPickMerck turns to China-based SciBrunch for KRAS program, pays $400M up front: Deals Report
Merck & Co. has licensed global rights to SPR2015, a preclinical KRAS G12D molecular glue inhibitor from China-based SciBrunch, paying $400 million up front. The deal follows reported failed M&A negotiations with Revolution Medicines in the $30 billion range, after that company reported in April that daraxonrasib led to a survival benefit in pancreatic cancer patients. Further deal terms for the SciBrunch agreement were not disclosed.
- mp.weixin.qq.comPickFDA Approves Daraxonrasib as First Oral RAS-Targeted Drug for Pancreatic Cancer
The FDA approved Rasonque (daraxonrasib) on August 26, 2026 for metastatic pancreatic adenocarcinoma in patients previously treated with at least one systemic therapy. It is the first direct RAS-targeted oral drug approved in pancreatic cancer, a disease where more than 90% of patients carry KRAS mutations. The approval comes 44 years after RAS was identified as the first human oncogene in 1982.
- STAT NewsOpinion: STAT+: The NIH budget should be $100 billion per year
Reed Jobs argues in a STAT+ opinion piece that the U.S. NIH annual budget should be raised to $100 billion, strengthening rather than weakening investment in research. He cites daraxonrasib, a KRAS-targeting drug from Revolution Medicines, which the FDA approved in late August for previously treated KRAS-mutant pancreatic cancer and which nearly doubled survival rates in a clinical trial.
- mp.weixin.qq.comPickTam-Peli Extends Survival in Recurrent SCLC; Daraxonrasib Active in RAS-Mutant NSCLC
At the World Conference on Lung Cancer in Seoul, the B7-H3 antibody-drug conjugate Tam-Peli prolonged survival in recurrent small cell lung cancer, with median overall survival of 13.3 months versus 9.4 months (HR 0.46, P<0.001), results published simultaneously in NEJM. The RAS(ON) inhibitor daraxonrasib also showed activity in RAS-mutant non-small cell lung cancer.
- biocentury.comSix first-in-class approvals in August
FDA approved six first-in-class drugs in August. Among them, Revolution Medicines' RAS(ON) inhibitor Rasonque daraxonrasib was approved just 40 days after submission under the Commissioner's National Priority Review Voucher (CNPV) program.
- mp.weixin.qq.comPickFDA Approves Revolution Medicines' Daraxonrasib for Metastatic Pancreatic Cancer
On August 26, 2026, the FDA approved Revolution Medicines' Rasonque (daraxonrasib, formerly RMC-6236) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior line of systemic therapy. It is the first FDA-approved targeted therapy aimed at the active-state RAS(ON) protein family. The RAS(ON) molecular glue approval marks one of the biggest clinical advances in pancreatic cancer in nearly a decade.
- statnews.comSTAT+: We’re reading about an Ultragenyx failure, RevMed for lung cancer, and more
Ultragenyx's gene therapy GTX-102 for Angelman syndrome failed to show benefit versus sham control in a Phase 3 trial, and the company announced plans for "significant expense reductions." Revolution Medicines' daraxonrasib (Rasonque) shrank tumors in more than 30% of patients in a small trial in previously treated NSCLC with RAS mutations; a larger randomized study is underway.
- mp.weixin.qq.comPickFDA Approves Revolution's RAS(ON) Inhibitor Daraxonrasib for Metastatic Pancreatic Cancer
The FDA approved Revolution's RASONQUE (daraxonrasib), a once-daily oral tablet, for adults with metastatic pancreatic ductal adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multi-drug combination systemic therapy. The approval on 26 August 2026 came about 6.5 months ahead of the original FDA target date. Daraxonrasib is the first approved RAS(ON) multi-selective inhibitor and the first RAS-targeted drug for metastatic PDAC that broadly inhibits multiple RAS mutations.
- N Engl J MedPickDaraxonrasib for Previously Treated RAS-Mutant Non-Small-Cell Lung Cancer.
Daraxonrasib (RMC-6236), an oral RAS(ON) multiselective inhibitor, showed antitumor activity in 136 previously treated patients with advanced RAS-mutant NSCLC: objective response occurred in 31% at doses of 120 mg or less, 34% at 160 to 220 mg, and 37% at 300 mg once daily. Adverse events of grade 3 or higher occurred in 54%, including four grade 5 events, with rash, diarrhea, nausea, vomiting, and mucositis or stomatitis each affecting at least 30% of patients.
- mp.weixin.qq.comPickFDA Approves Revolution Medicines' RASONQUE (daraxonrasib) for Metastatic Pancreatic Cancer
The FDA approved Revolution Medicines' RASONQUE (daraxonrasib) on August 26 for metastatic pancreatic cancer. It is the first approved drug worldwide to directly target RAS. The approval marks a first for the RAS-targeting class in pancreatic cancer.
- mp.weixin.qq.comPickFDA Approves Revolution Medicines' Pan-RAS Inhibitor Rasonque for Metastatic Pancreatic Cancer
The US FDA has approved Revolution Medicines' oral pan-RAS inhibitor Rasonque (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not suited to multi-drug combination systemic therapy. The approval follows overall survival benefit shown in a phase 3 trial. Rasonque works through a molecular-glue ternary complex strategy targeting RAS, a target once considered undruggable.
- mp.weixin.qq.comPickFDA Grants Early Approval to Daraxonrasib, World's First RAS(ON) Inhibitor, for Pancreatic Cancer
The FDA has granted early approval to Daraxonrasib, the first RAS(ON) inhibitor cleared anywhere in the world, for pancreatic cancer. The decision gives patients with KRAS-mutation-driven pancreatic cancer, a disease with a 5-year relative survival rate of just 3%, a targeted therapy option after years when no targeted drug was available. The approval moves pancreatic cancer treatment from a chemotherapy-dominated approach toward precision targeting.
- mp.weixin.qq.comPickFDA Approves Revolution Medicines' RAS Inhibitor Rasonque for Metastatic Pancreatic Cancer
The FDA approved Revolution Medicines' first-in-class RAS inhibitor Rasonque (daraxonrasib) on August 26 for adults with metastatic pancreatic ductal adenocarcinoma who have received at least one prior systemic therapy or are not suited for multi-drug systemic treatment. It is the first RAS-targeted therapy for the most common type of pancreatic cancer. The drug was reviewed under the FDA commissioner's national priority voucher pilot programme, and approval came one month after the application was accepted, 6.5 months ahead of the PDUFA goal date.
- mp.weixin.qq.comPickFDA Grants Early Approval to Revolution Medicines' RAS(ON) Inhibitor Daraxonrasib for Pancreatic Cancer
The FDA approved Revolution Medicines' Rasonque (daraxonrasib), the first RAS(ON) inhibitor to reach the market, on August 26, months ahead of expectation. The once-daily tablet targets multiple forms of RAS protein, a key driver of tumor growth in most pancreatic cancer patients, and offers a new treatment option for the most common form of advanced pancreatic cancer, which arises from cells lining the pancreatic ducts.
- mp.weixin.qq.comPickFDA Approves Daraxonrasib, First RAS(ON) Inhibitor, for Pretreated Metastatic Pancreatic Cancer
The US FDA has approved Revolution Medicines' pan-RAS inhibitor daraxonrasib, brand name Rasonque, for previously treated metastatic pancreatic cancer (PDAC). The drug, the company's lead pipeline asset and the first RAS(ON) inhibitor approved worldwide, is active against G12, G13, Q61 and wild-type RAS. Late-stage trials are already underway in first-line, second-line and adjuvant pancreatic cancer settings.
- mp.weixin.qq.comPickFDA Approves Revolution Medicines' Daraxonrasib for Metastatic Pancreatic Cancer Ahead of Schedule
The FDA approved Revolution Medicines' daraxonrasib (RMC-6236, brand name Rasonque) on August 26 for patients with metastatic pancreatic cancer who have received at least one prior systemic therapy or are not suited to multiple systemic therapies. The oral RAS(ON) multi-selective non-covalent inhibitor blocks interactions between wild-type and mutant RAS(ON) proteins and downstream effectors, and the FDA said the approval came 6.5 months ahead of schedule.
- nature.comPickRevMed’s RAS inhibitor gains landmark FDA approval for pancreatic cancer
The US FDA has approved Revolution Medicines' daraxonrasib (Rasonque) for pancreatic adenocarcinoma patients who have received at least one prior systemic therapy or are not eligible for multiagent systemic therapy. It is the first broadly active RAS-targeted inhibitor to reach market, unlike the KRAS G12C-specific inhibitors sotorasib (Lumakras) and adagrasib (Krazati), which are approved only in NSCLC and colorectal cancer subsets.
- biocentury.comPickRevMed’s first-in-class pancreatic therapy among fastest CNPV approvals
FDA approved Revolution Medicines' daraxonrasib (Rasonque) for pancreatic ductal adenocarcinoma, making it the first targeted therapy in the new RAS(ON) inhibitor class and the first new cancer drug cleared under the commissioner's national priority review voucher initiative. Revolution Medicines (NASDAQ:RVMD) is launching the drug immediately at a WAC of $39,800 for a 30-day supply.
- statnews.comPickSTAT+: FDA approves new pancreatic cancer drug expected to usher in new era of treatment
The FDA has approved Revolution Medicines' Rasonque (daraxonrasib) as a second-line treatment for advanced pancreatic cancer, the first drug to target a genetic cause of the disease. In the pivotal trial supporting approval, the Rasonque arm achieved a median overall survival of 13.2 months versus 6.7 months with standard chemotherapy. UCSF gastrointestinal oncologist Andrew Ko called it the biggest advance in pancreatic cancer treatment in decades.
- 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.
- fda.govPickFDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer
The FDA approved Revolution Medicines' Rasonque (daraxonrasib), a once-daily RAS inhibitor, for adults with metastatic pancreatic adenocarcinoma who have had at least one prior systemic therapy or are not candidates for multiagent systemic therapy. In a 500-patient randomized trial, Rasonque improved median overall survival to 13.2 months versus 6.7 months on standard chemotherapy. The approval came 6.5 months ahead of the user fee deadline, under Breakthrough Therapy, Orphan Drug and Priority Review designations and the National Priority Voucher pilot program.
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