Key Takeaway:
- Daraxonrasib nearly doubled survival time for pancreatic cancer patients in a major clinical trial, generating significant interest among patients and doctors.
- High demand and administrative requirements are slowing access to the experimental drug through Revolution Medicines’ expanded access program.
- Patients awaiting pancreatic cancer treatment remain hopeful, while concerns persist about supply availability and how quickly eligible individuals can receive the drug.
Pancreatic cancer patients across the United States are racing to obtain access to the experimental drug daraxonrasib through an expanded access program, but high demand and administrative hurdles are causing delays despite promising clinical trial results.
Daraxonrasib, developed by Revolution Medicines, nearly doubled median overall survival for previously treated metastatic pancreatic cancer patients in a Phase 3 trial. The drug extended survival to 13.2 months compared with 6.7 months for patients receiving standard chemotherapy and reduced the risk of death by 60%, according to trial data presented last week.
The U.S. Food and Drug Administration authorized an expanded access program in May, allowing eligible patients with advanced pancreatic cancer to receive the investigational treatment before formal approval. Physicians must submit requests on behalf of patients.
For many patients, however, obtaining the drug remains uncertain.
Amy Johnston, a 35-year-old Pennsylvania mother of three diagnosed with pancreatic cancer last year, said she hopes to pursue daraxonrasib if her current clinical trial treatment fails.
“This is such a small company, and I worry their production is not able to keep up with the need,” Johnston told STAT. “Who receives it first?”
Bureaucratic delays slow access to promising cancer treatment
Patients and physicians report concerns about processing times, supply availability, and the administrative requirements needed to secure access. The expanded access pathway requires physician participation and regulatory review before Pancreatic cancer treatment can begin.
The intense interest follows widespread attention from oncologists and patient groups after the drug’s trial results were presented at the annual meeting of the American Society of Clinical Oncology. Experts described the findings as a major advance for a cancer type with historically limited treatment options.
Dr. Zev Wainberg of the University of California, Los Angeles, one of the study leaders, said the treatment represents significant progress.
“While not curing the cancer, it is a very large step forward,” Wainberg told CBS News.
Revolution Medicines works to meet growing patient requests
Revolution Medicines says it is moving quickly to provide access while maintaining safety and oversight. The company began shipping daraxonrasib under the FDA-authorized program in late May, according to Chief Executive Officer Mark Goldsmith.
The FDA approved the expanded access request within two days of receiving it, citing the urgent need for treatment options for patients with life-threatening diseases.
Industry analysts and oncologists widely expect daraxonrasib to receive approval as a second-line treatment for metastatic pancreatic cancer treatment. Additional studies are examining whether the drug could benefit patients earlier in the course of the disease and in other cancers driven by RAS mutations.
For patients awaiting access, the challenge remains balancing hope with uncertainty as demand for the experimental therapy continues to grow.
