The FDA approved daraxonrasib for previously treated metastatic pancreatic adenocarcinoma.
Why it matters: The drug gives oncologists a new treatment option for a cancer with few effective choices. It also adds momentum to efforts to develop medicines aimed at RAS, a long-sought target in oncology.
- The FDA approved daraxonrasib for adults with metastatic pancreatic adenocarcinoma who have had at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
- The agency said the decision marks the first approved targeted therapy in pancreatic cancer that directly targets RAS.
- In the phase 3 RASolute 302 trial, median overall survival was 13.2 months with daraxonrasib versus 6.7 months with standard chemotherapy.
- Revolution Medicines will market the drug as Rasonque, according to STAT.
The FDA approved daraxonrasib for adults with metastatic pancreatic adenocarcinoma who have already received at least one systemic therapy, or who are not candidates for multiagent systemic therapy.
Revolution Medicines will market the drug as Rasonque, STAT reported. The FDA said the approval is the first approved targeted therapy in pancreatic cancer to directly target RAS, a cancer-driving pathway.
The agency said the decision was based on the phase 3 RASolute 302 trial, a randomized, open-label, multicenter study of 500 previously treated patients with metastatic pancreatic adenocarcinoma. Dana-Farber, which helped lead the study, said median progression-free survival was 7.2 months with daraxonrasib versus 3.6 months with standard chemotherapy.
The FDA said it approved the drug 6.5 months ahead of the user fee deadline under the Commissioner’s National Priority Voucher pilot program. It also cited breakthrough therapy, orphan drug and priority review designations.
FDA-listed side effects include rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite and hemorrhage.
Acting FDA Commissioner Kyle Diamantas said the approval provides a critical new option for patients facing an extraordinarily difficult cancer. Dana-Farber cancer specialist Brian Wolpin said the approval is a meaningful step for the field.
By the numbers
- 13.2 months - Median overall survival with daraxonrasib in RASolute 302, versus 6.7 months with standard chemotherapy.
- 7.2 months - Median progression-free survival with daraxonrasib, versus 3.6 months with standard chemotherapy, according to Dana-Farber.
- 500 patients - Size of the randomized, open-label, multicenter RASolute 302 trial.
Yes, but: The approval is limited to previously treated metastatic pancreatic adenocarcinoma, so it does not expand treatment to all pancreatic cancer patients.
What's next: Clinicians can now use daraxonrasib for the approved metastatic pancreatic cancer indication, while further study will determine how broadly the drug fits into treatment sequencing.