The FDA’s approval of daraxonrasib represents an important step forward for patients with metastatic pancreatic cancer, where treatment options are limited.
Daraxonrasib, a first-in-class targeted therapy for previously treated metastatic pancreatic ductal adenocarcinoma, represents an important moment for patients, researchers and the broader oncology community.
The approval is especially meaningful for SCRI because it reflects years of work supporting the development of the therapy across multiple stages of research, from early clinical studies to the pivotal trial that ultimately helped bring the therapy to patients.
A Breakthrough Moment in Pancreatic Cancer Research
Highly anticipated results from the Phase III RASolute-302 study were presented during the plenary session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, drawing significant attention from the oncology community. The results showed meaningful outcome improvements for patients with previously treated metastatic pancreatic cancer and helped establish daraxonrasib as a potential new standard of care.
Designed to inhibit RAS-driven cancers, daraxonrasib targets a pathway long recognized as one of the primary drivers of pancreatic cancer. Daraxonrasib is the first therapy of its kind to inhibit KRAS-driven pancreatic cancer and provides a critical new option for this historically hard-to-treat cancer.
SCRI's Role Across the Development Journey
SCRI's involvement with daraxonrasib began well before the therapy made headlines.
Early in the drug’s development, SCRI investigators conducted a Phase I/II clinical trial at SCRI Oncology Partners, helping researchers better understand the therapy's safety and potential efficacy, and inform future studies.
SCRI’s participation continued through the pivotal Phase III trial, which compared daraxonrasib with standard-of-care treatment in patients with previously treated pancreatic cancer. The SCRI Network enrolled more than 20 patients on the trial across three research sites – Rocky Mountain Cancer Centers, Texas Oncology and SCRI Oncology Partners.
Expanding Access While Research Continued
Earlier this year, the FDA authorized an Expanded Access Program for daraxonrasib, providing a pathway for eligible patients with metastatic pancreatic cancer who could not participate in a clinical trial and lacked comparable or satisfactory treatment alternatives to receive the investigational therapy while FDA review was ongoing. At that time, daraxonrasib had not been approved by FDA, and its safety and effectiveness for this use had not been established.
A total of 13 SCRI-affiliated research sites participated in the Expanded Access Program, through which eligible patients could receive the therapy while FDA review was underway.
The effort reflects SCRI's ongoing commitment to making investigational therapies available to eligible patients to support the evidence generation required for regulatory review.
Looking Ahead
Although today's approval marks a significant milestone, the work is far from over.
SCRI continues to support the clinical development of daraxonrasib through studies evaluating the therapy in earlier lines of treatment and additional disease settings. Researchers hope those efforts will further expand the impact of the therapy.
For SCRI, this approval underscores the vital role each stakeholder plays in the research process and demonstrates how scientific innovation, clinical expertise and patient participation can help bring important new therapies to patients faster.