New FDA-Approved Drug Offers Hope for Advanced Pancreatic Cancer Patients

New FDA-Approved Drug Offers Hope for Advanced Pancreatic Cancer Patients

Florida Cancer Specialists & Research Institute Research Helps Pave The Way for Ongoing Treatment Breakthroughs

The U.S. Food and Drug Administration (FDA) recently approved daraxonrasib, a new targeted therapy for certain patients with metastatic pancreatic cancer, marking a significant advancement for a disease with historically limited treatment options and poor survival. The approval follows years of research and clinical investigation and highlights the critical role of clinical research in translating scientific discoveries into new treatment options for patients.

Florida Cancer Specialists & Research Institute (FCS) contributed to the development of daraxonrasib through participation in early-phase clinical trials and is actively participating in ongoing studies exploring new applications for the therapy in pancreatic cancer and other cancers.

FCS Associate Director of Drug Development Judy Wang, MD served as principal investigator for two early phase clinical trials with daraxonrasib, helping generate data that informed subsequent studies and the therapy’s path to FDA approval.

“The approval of daraxonrasib is one of the first major advances for pancreatic cancer treatment in decades,” Dr. Wang said. “Having treated patients on early phase trials, we have had first-hand experience in seeing the positive results, not only with improvement on restaging scans and tumor markers, but also clinical improvement with reduced cancer pain and tumor-related symptoms.”

Daraxonrasib is a once-daily oral medication designed to block abnormal RAS/KRAS proteins, which drive the growth of most pancreatic cancers. For decades, researchers have sought ways to target these cancer-causing proteins.

The FDA’s decision was based on results from a large phase 3 clinical trial involving 500 patients with previously treated metastatic pancreatic cancer. Patients who received daraxonrasib stayed on treatment longer than compared to chemotherapy and lived almost twice as long, with improved survival 13.2 versus 6.7 months. “In a patient population that has aggressive disease, limited treatment options, and generally poor prognosis with median overall survival of six to 11 months, this is literally groundbreaking,” said Dr. Wang.

“This is a huge win for patients because of research,” noted Amanda Olson, MD, FCS medical director of late-phase clinical research. “FCS remains actively engaged in paving the way for additional advances against pancreatic cancer and other cancers driven by RAS mutations,” she added.

FCS is offering patients new opportunities to access this highly promising therapy through an active Phase 3 clinical trial for certain lung cancer patients and a Phase 3 study of adjuvant daraxonrasib in patients with resected pancreatic ductal adenocarcinoma (PDAC).

FCS provides access to clinical trial options in all phases across 29 locations in Florida, including two early-phase drug development units, connecting patients to a network of clinical trials unsurpassed by any single cancer center in Florida.

“Participation in clinical trials offers patients the most reliable path to access, strengthens our research mission and may provide a life-extended treatment when it is needed most,” Dr. Olson said.

Sources

U.S. Food and Drug Administration (FDA), New England Journal of Medicine phase 3 trial findings, Associated Press reporting, and expert commentary from Dana-Farber Cancer Institute.

Facts About Pancreatic Cancer

• Pancreatic cancer remains one of the most challenging cancers to diagnose and treat.
• In 2026, an estimated 67,530 Americans will be diagnosed with pancreatic cancer and approximately 52,740 will die from the disease, making it one of the leading causes of cancer-related death despite accounting for only about 3% of all new cancer diagnoses.
• Incidence rates have gradually increased over the past decade, and experts project pancreatic cancer will become an even greater public health concern as the population ages.
• Because symptoms often do not appear until the disease has advanced, the overall five-year survival rate remains approximately 13%, underscoring the critical need for earlier detection and more effective treatments.

Signs, Symptoms & Risk Factors

Pancreatic cancer often does not cause noticeable symptoms in its early stages. Although the exact cause of pancreatic cancer is unknown, several factors can increase risk. These include older age, smoking, obesity, diabetes, chronic pancreatitis and a family history of the disease. About 1 in 10 pancreatic cancers is linked to inherited genetic mutations, so individuals with a close relative diagnosed with pancreatic cancer may want to discuss genetic counseling or testing with their physician.