Pancreatic cancer is one of the deadliest cancers in the United States, but it can develop without many noticeable symptoms. Many patients are only diagnosed after the cancer has metastasized, leaving them with limited treatment options. For Black patients in particular, who are often diagnosed with advanced pancreatic cancer, it can be life-threatening.
According to the Pancreatic Cancer Action Network (PanCAN) and the National Cancer Institute (NCI), Black Americans have a disproportionately high incidence rate of pancreatic cancer. A 2025 study reported “evidence of racial disparities in pancreatic cancer mortality, with Black/African American and Asian/Pacific Islander individuals facing significantly higher odds of mortality compared to white individuals. These findings underscored the need for targeted interventions and policies to address these inequities and promote health equity in pancreatic cancer outcomes.”
This is why developments presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting about the Phase 3 RASolute 302 clinical trial of daraxonrasib have such promise for Black patients and their families. This targeted therapy for patients with metastatic pancreatic cancer found that people receiving daraxonrasib experienced a median survival that was approximately twice as long as those receiving standard chemotherapy. While the daily pill has not yet received FDA approval, the trial’s results have spurred an accelerated review and access to the FDA’s Expanded Access Program.
Pancreatic cancer has many triggers, including tobacco use, long-standing type 2 diabetes, and inherited BRCA gene changes.
“‘Metastatic’ means the cancer has spread beyond the pancreas to other parts of the body,” explained Pashtoon Kasi, MD, medical director of GI Medical Oncology at City of Hope Orange County. “Today, advances in chemotherapy, biomarker testing, and clinical trials are improving care for many patients.”
Currently, chemotherapy, radiation, and pancreaticoduodenectomy surgery are standard approaches to remove tumors and related disorders. Each, however, has its own risks and a strenuous post-treatment recovery plan. The promise of a new treatment that is more effective and has fewer severe side effects is a game-changer in the field of oncology.
Unlike traditional chemotherapy, which can be administered through intravenous (IV) infusion, oral pills, and direct injections, daraxonrasib is a pill taken daily to target one of pancreatic cancer’s most important molecular drivers. Chemo attacks healthy and unhealthy cells alike, but this experimental drug promises precision.
“Most pancreatic cancers are driven by changes in a gene called KRAS (Kirsten rat sarcoma viral oncogene homolog), which acts like an accelerator pedal that’s stuck to the floor, continuously signaling cancer cells to grow and divide,” Dr. Kasi explained. “For decades, KRAS was considered one of the most difficult targets in cancer research.” KRAS creates the K-Ras protein, which is responsible for controlling cell growth and division.
According to the American Cancer Society (ACS), this experimental targeted therapy specifically turns off the K-Ras proteins. Yet, when RAS is abnormal, cells can grow excessively and become cancerous. “About 90 percent of pancreatic cancers are linked to changes in RAS, as well as many other cancers, including some lung and colorectal cancers,” the article read.
The recently presented Phase 3 trial results demonstrate a significant survival advantage compared with standard chemotherapy, as well as an improved quality of life.
Dr. Kasi noted that City of Hope was one of 59 centers worldwide that participated in the pivotal trial.
Although the investigational therapy has generated considerable enthusiasm, it may be many more months — if not years — before daraxonrasib is a mainstream treatment option.
Physicians should consider biomarker testing for new patients or suspected cases, since targeted therapies require identifying the molecular characteristics of a tumor. “We also strongly believe in providing access and implementing the recommendations of universal germline testing, since a fraction of pancreatic cancer can be caused by the breast cancer (BRCA) family of genes that can be running in the family,” Dr. Kasi said. Testing both the patient and the tumor can identify individuals who may benefit from treatments beyond standard chemotherapy, while also providing valuable information to family members who may be at increased hereditary risk.
The FDA accepted the manufacturer’s New Drug Application on July 22, 2026, through the Commissioner’s National Priority Voucher Program, which accelerates review of therapies that address severe unmet medical needs. This process cuts down the traditional 10- to 12-month review period to just one to two months instead.
“For eligible patients who have exhausted other treatments, the FDA’s expanded access program available at City of Hope and locations across the country provides eligible patients with access to the investigational therapy before potential FDA approval,” Dr. Kasi said.
For practicing clinicians, this highlights the importance of discussing clinical trials and expanded access sooner rather than later. Patients not seeing results with conventional therapies may qualify for targeted therapies and referrals to academic medical centers or cancer programs participating in investigational studies.
Daraxonrasib is not yet standard treatment, but the Phase 3 results offer one of the most encouraging advances in recent years for a disease that has had few therapeutic breakthroughs. While the world awaits the FDA’s decision, physicians can begin educating patients about targeted therapies, refer eligible patients for biomarker and germline testing, and suggest clinical trial opportunities early in patients’ treatment journey.
For Black patients, physicians can help narrow racial disparities by increasing participation in clinical research and improving access to specialized cancer centers that use precision medicine. These clinical trial results offer a significant glimmer of hope for a cure to this aggressive form of cancer, but FDA approval is not expected until late 2026.
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