The FDA has approved Rasonque (daraxonrasib) for adults with advanced pancreatic cancer that has stopped responding to earlier treatment, or for patients too sick for standard combination chemotherapy. The drug improved median overall survival to 13.2 months compared with just 6.7 months for standard chemotherapy.
It is the first targeted drug approved for pancreatic cancer that acts on multiple forms of RAS, a protein that drives tumor growth in most pancreatic adenocarcinoma cases, according to an Aug. 26 FDA news release. RAS mutations eluded targeted therapies for decades — a gap that a new wave of RAS inhibitors, including Rasonque, is only now beginning to close.
The survival data came from a randomized, open-label trial of 500 adults with previously treated metastatic pancreatic adenocarcinoma. The result builds on earlier trial data showing daraxonrasib extended median progression-free survival by 8.5 months and outperformed chemotherapy in both overall and progression-free survival — findings that had already driven cancer centers nationwide to prepare for a surge in patient demand months before approval.
The FDA granted Rasonque breakthrough therapy and orphan drug designations and reviewed the application under priority review and the Commissioner’s National Priority Voucher pilot program. The approval came 6.5 months ahead of the agency’s user fee deadline. Revolution Medicines, the drug’s manufacturer, received a “safe to proceed” letter from the FDA in May allowing expanded access to the drug ahead of approval.
Pancreatic adenocarcinoma accounts for 90% to 95% of the 67,000 pancreatic cancer cases diagnosed in the U.S. each year, according to the National Cancer Institute. Though it represents about 3.2% of all cancer diagnoses, the cancer type causes a disproportionately high share of cancer deaths due to late detection and historically limited treatment options.
A phase 3 trial of daraxonrasib is underway at more than 30 cancer centers in the U.S., and could expand the drug’s use to earlier lines of treatment if results hold up.
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