Daraxonrasib Approved for Previously Treated Metastatic Pancreatic Cancer

The US FDA approved daraxonrasib (Rasonque), an oral, multiselective RAS(ON) inhibitor, for the treatment of adults with metastatic pancreatic adenocarcinoma with at least one prior systemic therapy or who are not candidates for multiagent systemic therapy, according to Revolution Medicines, the manufacturer of daraxonrasib.

The approval was based on data from the RASolute 302 study, which compared daraxonrasib with investigator’s choice chemotherapy in patients with previously treated metastatic pancreatic cancer, according to a press release from Revolution Medicines. 

In the phase 3 RASolute 302 trial, daraxonrasib significantly improved median overall survival (OS) at 13.2 months compared with chemotherapy at 6.7 months (HR, 0.40; 95% CI, 0.30–0.53; P < .0001) for the overall population. Daraxonrasib also significantly improved progression-free survival (HR, 0.49; 95% CI, 0.38–0.64; P < .0001). Survival outcomes were consistent in the RAS G12–mutated subgroup, according to the press release. 

“For decades, despite RAS being the main driver and potential drug target for pancreatic cancer, physicians have largely relied on intravenous cytotoxic chemotherapy to treat this aggressive disease,” said Brian Wolpin, MD, MPH, principal investigator for RASolute 302 and director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute. “This approval gives physicians the confidence that directly inhibiting RAS can make a striking difference for patients and provides a critically needed new approach to treating patients with metastatic pancreatic cancer.”