On August 26, 2026, the U.S. Food and Drug Administration approved Rasonque (daraxonrasib), a first-in-class targeted oral therapy for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. Rasonque is administered as a once-daily tablet and was developed to inhibit multiple forms of the RAS protein, a central driver of tumor growth in pancreatic adenocarcinoma.
The approval follows results from a randomized, open-label, multicenter clinical trial that enrolled 500 adults with previously treated metastatic pancreatic adenocarcinoma. In that trial, Rasonque improved median overall survival to 13.2 months compared with 6.7 months for standard chemotherapy, according to the source. The magnitude of the survival improvement and the drug’s mechanism underpin its characterization as a novel option in a disease with historically limited effective treatments.
Regulatory designations granted to Rasonque included Breakthrough Therapy and Orphan Drug status, and the marketing application received Priority Review. The application was also reviewed under the Commissioner’s National Priority Voucher pilot program, which aims to accelerate review of therapies addressing national public health priorities. Earlier, in May, the FDA issued a “safe to proceed” letter that permitted an expanded access treatment protocol, enabling investigational access before full approval under applicable FDA regulations.
The FDA public statements cited the urgency of advancing treatments for pancreatic adenocarcinoma, noting that this cancer type comprises the majority (approximately 90–95%) of the roughly 67,000 U.S. pancreatic cancer cases diagnosed annually and carries a disproportionate share of cancer mortality due to late detection and aggressive course.
Reported common adverse events observed with Rasonque include rash, diarrhea, stomatitis (inflammation of the mouth’s mucous membranes), nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage. The approval was granted to Revolution Medicines, Inc., per the source.
On August 28, 2026, Eli Lilly and Company announced FDA approval of Mounjaro (tirzepatide) to lower the risk of major adverse cardiovascular events (MACE)—defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke—in adults with type 2 diabetes who are at high risk for these events. Mounjaro was already approved as an adjunct to diet and exercise to improve glycemic control in adults and children aged 10 years and older with type 2 diabetes.
The regulatory decision was based on results from SURPASS-CVOT, described in the source as the first cardiovascular outcomes trial to compare two incretin therapies head-to-head rather than against placebo. SURPASS-CVOT is also noted as the largest and longest tirzepatide study to date, enrolling more than 13,000 participants across 30 countries over more than four and a half years.
In SURPASS-CVOT, Mounjaro demonstrated non-inferiority to Trulicity (dulaglutide)—a GLP-1 receptor agonist with established cardiovascular benefit—and showed an 8% lower rate of MACE-3 (time to first event of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) compared with dulaglutide. The estimated hazard ratio for time to first MACE was reported as 0.92 with a 95.3% confidence interval of 0.83 to 1.01 for Mounjaro versus dulaglutide.
Investigators and company leaders quoted in the source emphasized integrating cardiovascular risk mitigation into diabetes care alongside glucose management. An Endocrine Society member cited in the report highlighted that heart disease is the leading cause of death for people with type 2 diabetes and that this approval provides a therapy that reduces cardiovascular risk while supporting metabolic outcomes such as A1C and weight.
The safety and tolerability profile of Mounjaro in SURPASS-CVOT was consistent with its established profile. The most commonly reported adverse events were gastrointestinal in nature, generally mild-to-moderate in severity, and occurred primarily during dose escalation. The source directs readers to the Indications and Safety Summary with Warnings and full Prescribing Information and Medication Guide for additional details.
For clinicians, the SURPASS-CVOT findings represent evidence from a large, long-duration, international head-to-head trial comparing two incretin-based therapies with cardiovascular endpoints. The reported non-inferiority to a GLP-1 agent with known cardiovascular benefit and the observed 8% lower rate of MACE-3 form the basis for the new indication in patients with type 2 diabetes at high cardiovascular risk.