The U.S. Food and Drug Administration (FDA) on Wednesday approved Revolution Medicines Inc.’s (NASDAQ:RVMD) Rasonque (daraxonrasib) for metastatic pancreatic adenocarcinoma (PDAC).
Specifically, it targets patients who previously underwent at least one systemic therapy or those ineligible for multiagent systemic treatment.
Rasonque marks the first approved targeted cancer therapy from a new class of RAS(ON) multi-selective and mutant-selective inhibitors.
Phase 3 Trial Drives Regulatory Nod
The FDA based its decision on data from the RASolute 302 Phase 3 clinical trial. The global, randomized study pitted Rasonque against investigator-selected cytotoxic chemotherapy in patients battling previously treated metastatic PDAC.
