Hoping to develop better methods to treat pancreatic cancer — one of the most aggressive, deadly types of cancer — the United States Food and Drug Administration (FDA) is speeding up its review of a drug called daraxonrasib to see if it may deliver better results for patients.
Pancreatic cancer is one of the toughest cancers to diagnose and treat, explains oncologist Christopher Lieu, MD, a professor of medical oncology at the University of Colorado Anschutz Department of Medicine and associate director of clinical research at the CU Anschutz Cancer Center. For decades, scientists have struggled to develop better treatments, often having to rely on chemotherapy — a treatment that works for some but not for many others.
Initial research suggests that daraxonrasib, a targeted drug therapy, could potentially be more effective than chemotherapy. However, before the FDA can deem the drug to be a safe and viable option, the agency must conduct a thorough review. This approval process typically takes 10-12 months, but thanks to a new federal pilot program, the FDA is expediting the process to take one to two months following the filing of a complete application.
“There are certain diseases where getting access to promising drugs may mean the difference between life and death, and pancreatic cancer is an example of this,” Lieu says. “There are not enough treatment options, and our patients don’t have the luxury of waiting years for any regulatory agency to review data. The idea that the FDA has a pathway for accelerated review is important and exciting, but it’s a new program, so I think there’s still a lot we’ll have to learn from it.”
We recently spoke with Lieu about what is known about daraxonrasib, the lingering questions surrounding the drug, and the potential benefits and limitations of an expedited FDA review process.
The following interview has been edited and condensed.