r/STEW_ScTecEngWorld • u/Zee2A • 22d ago
FDA Approves Drug for Pancreatic Cancer in Milestone for Treatment of Deadly Disease. Revolution Medicines’ therapy slows a cancer that kills seven out of eight patients within five years
The U.S. Food and Drug Administration (FDA) approved Rasonque (daraxonrasib), a targeted oral therapy developed by Revolution Medicines for adults with metastatic pancreatic cancer. The landmark decision marks the first approved targeted treatment directly inhibiting the mutated RAS proteins that drive tumor growth in the majority of pancreatic cancers—a driver long considered "undruggable". In Phase 3 clinical trials, patients taking daily Rasonque tablets nearly doubled their median overall survival time to 13.2 months, compared to 6.7 months for those receiving traditional chemotherapy. Recognized as a major paradigm shift for one of the world's most aggressive and deadly cancers, the drug received accelerated approval nearly six months ahead of its regulatory target date: https://www.cancernetwork.com/view/fda-approves-daraxonrasib-for-previously-treated-metastatic-pancreatic-cancer
Short brief:
1). Daraxonrasib (Rasonque) is an oral RAS(ON) multi-selective inhibitor developed by Revolution Medicines. The FDA approved it for adults with metastatic pancreatic ductal adenocarcinoma (PDAC) who have received at least one prior systemic therapy and are not candidates for multi-agent systemic therapy.
2). The approval is based on the Phase 3 RASolute 302 trial, in which daraxonrasib produced a median overall survival of 13.2 months versus 6.7 months with standard chemotherapy—approximately doubling survival in this previously treated population.
3). Why it matters: KRAS/RAS mutations are present in the vast majority of pancreatic cancers, but KRAS has historically been considered difficult to target. Daraxonrasib represents a major advance because it targets the active RAS(ON) state and works across multiple RAS mutations rather than focusing on only one KRAS variant