FDA Expedites Review of Daraxonrasib for Pancreatic Cancer Treatment
The FDA is accelerating its review of daraxonrasib, a targeted therapy for pancreatic cancer, under a new pilot program that could reduce approval time from 10-12 months to one to two months.
The United States Food and Drug Administration is speeding up its review of a drug called daraxonrasib to see if it may deliver better results for patients with pancreatic cancer, one of the most aggressive and deadly types of cancer. 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.
Initial research suggests that daraxonrasib, a targeted drug therapy, could potentially be more effective than chemotherapy. The drug has demonstrated impressive efficacy in hard-to-treat cancers, with high objective response and disease control rates, significantly outperforming existing standard treatments.
Daraxonrasib (RMD-6236) is currently in phase 3 trials for advanced non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). The drug has received U.S. Food and Drug Administration Breakthrough Therapy Designation and inclusion in the FDA Commissioner's National Priority Review Voucher program, highlighting its promise and potential for accelerated approval.
Pancreatic cancer is one of the toughest cancers to diagnose and treat. 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. There are not enough treatment options, and patients don't have the luxury of waiting years for any regulatory agency to review data.
The drug is part of a class called RAS(ON) inhibitors, which aim to block the growth signals from RAS proteins in patients whose cancers are driven by changes in these proteins. Ongoing expansion into earlier lines of therapy and multiple combination studies in solid tumors are underway.
Sell-side analysts have projected that daraxonrasib's PDAC-only revenue could reach several billion dollars by the mid-2030s. 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.