April 17–22, 2026 · San Diego · 2418 items
← KRAS / RAS targeting: from platform to Phase 3
63 people · 65 posts · 6 abstracts
The floor also showed dual ON/OFF (VS-7375) and RM-055, built for amplification and daraxonrasib-resistant models.
| Drug / trial | Readout | Setting |
|---|---|---|
| daraxonrasibdaraxonrasib | mOS 13.2 vs 6.7 mo, HR 0.40 | RASolute 302 · 2L mPDAC · Phase 3 |
| daraxonrasib ± GnPdaraxonrasib#PANCREATICCANCER#PDAC | mono ORR 47%; +GnP ORR 55%, DCR 90% | 1L mPDAC · Phase 1 |
The floor rewrote the question from “how long can G12C monotherapy last” to “who first makes first-line pancreatic cancer a standard.” daraxonrasib’s Phase 3 is still the only RAS-inhibitor overall-survival win.
Nina Dashti-Gibson, Amy L. Olex, Rachel K. Myrick, Alexa M. Barber, David C. Boyd, Emily K. Zboril, Katarzyna M. Tyc, Mikhail G. Dozmorov, Guang-Yu Yang, Nicholas T. Woods, Jose G. Trevino, J Chuck Harrell
Read the abstract →Kayla Tyskiewicz, Markus Hippich, Tristan Cates, Gervaise Henry, Gilad Silberberg, Nicole Spanburg, Madeline Westcott, Daniel Ciznadija, Michael Boice, Paul Heverly, Frank Smith, Marianna Zipeto, Stefano Cairo, Sebastian Brabetz
Read the abstract →Nataliya Tovbis Shifrin, Mariela Moreno Ayala, Cristina Blaj, Kevin Chen, Felix Mbuga, Joaquin Pechuan Jorge, Rashi Raghulan, Rich Liang, Linh Tran, Enrico Payson, Alice Kumamoto, Alexander McNamara, Marie Josette Catherine Menard, Michael Weiss, Lillian Seu, Elsa Quintana
Read the abstract →Ferdinandos Skoulidis, Kathryn C. Arbour, Sanjay Popat, Colin R. Lindsay, Hidehito Hironouchi, Gérard Zalcman, Alessandra Curioni-Fontecedro, Jarushka Naidoo, Adrianus J. de Langen, Lin Tao, Erica Su, Minoti Hiremath, Achim Rittmeyer, Melissa Johnson
Read the abstract →Eileen M. O'Reilly, Brian Wolpin, Shubham Pant, Joel Randolph Hecht, Jennifer Valerin, Dae Won Kim, Nilofer Azad, Kyaw Aung, Lin Tao, Sumit Kar, Hina Patel, Rashmi Vora, Aparna Hegde, Alexander Spira, Alexander Starodub, Benjamin Herzberg, Ignacio Garrido-Laguna
Read the abstract →Brian M. Wolpin, Benjamin L. Musher, Gulam A. Manji, Wungki Park, Alexander Spira, Nilofer Azad, Vaia Florou, Tiago Biachi De Castria, Mark H. O'Hara, Erkut Borazanci, Aparna Parikh, John Strickler, Joel Randolph Hecht, Shubham Pant, Shiraj Sen, E. Gabriela Chiorean, W. Clay Gustafson, Hina Patel, Vidya Seshadri, Yan Zheng, Davendra Sohal
Read the abstract →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.
Why it matters: The article analyzes the daraxonrasib label controversy, arguing the vague wording is regulatory wisdom to cover real-world frail patients.
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.
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.
Why it matters: The source gives the timeline of the first approval under the CNPV pilot, letting readers compare it with standard priority-review PDUFA timing.
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.
Why it matters: The CHMP opinion specifies the indication and prior therapy lines, enabling timeline comparison with the same drug approved by FDA via a priority review voucher.
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.
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.
Why it matters: First EU approval recommendations for daraxonrasib and oral orforglipron plus key withdrawal and refusal decisions affecting patient access.
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.
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.
Why it matters: First approval extending RAS inhibition beyond KRAS G12C to multiple RAS mutations in pancreatic cancer.
EMA's human medicines committee (CHMP) has recommended approving the oral RAS inhibitor Rasonque (daraxonrasib) in the EU for adults with previously treated metastatic pancreatic adenocarcinoma. The applicant is Revolution Medicines. A phase 3 study enrolled 500 patients, 92% of whom carried a RAS G12 mutation; 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.
Why it matters: The brief gives median OS of 12.4 versus 6.7 months and PFS of 7.2 versus 3.6 months, letting readers gauge the clinical benefit.
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.
Why it matters: The article compares the first pan-RAS inhibitor Rasonque with existing KRAS G12C inhibitors to clarify its place among RAS-pathway drugs.
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.
Why it matters: First FDA approval of a RAS(ON) inhibitor shifts direct RAS targeting to a broader patient population.
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.
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.
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.
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.
Why it matters: Large upfront licensing payment by Merck for a preclinical KRAS G12D program after failed Revolution Medicines talks.
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.
Why it matters: First direct RAS-targeted oral approval in pancreatic cancer, an indication with heavy unmet need.
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.
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.
Why it matters: Reports survival benefit and new drug activity data from WCLC with simultaneous NEJM publication.
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.
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.
Why it matters: First FDA approval of a RAS(ON)-targeted therapy sets a new mechanism class in pancreatic cancer.
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.
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.
Why it matters: First RAS(ON) inhibitor approval covers a metastatic pancreatic cancer population with unmet need, ahead of schedule.
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.
Why it matters: First safety and efficacy data for a pan-RAS inhibitor across multiple doses in previously treated RAS-mutant NSCLC.
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.
Why it matters: First globally approved direct RAS-targeting drug, relevant to oncology drug development readers.
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.
Why it matters: First global approval of a RAS(ON) inhibitor for pancreatic cancer ends the lack of targeted options in KRAS-driven disease.
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.
Why it matters: First approval of a pan-RAS inhibitor for previously treated metastatic pancreatic cancer, a hard-to-treat indication.
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.
Why it matters: First RAS(ON) inhibitor approval worldwide, granted early for a hard-to-treat cancer.