Pancreatic Cancer

The FDA approved lutetium Lu 177 dotatate injection for adults with somatostatin receptor-positive GEP-NETs based on bridging data.

The U.S. Food and Drug Administration (FDA) has approved Rasonque (daraxonrasib), a RAS inhibitor for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. Granted to Revolution Medicines, Inc. on August 26, 2026, the first-in-class approval provides a new targeted treatment option […]

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib (LY3537982) as a monotherapy for the treatment of adult patients with advanced pancreatic cancer harboring a KRAS G12C mutation who have received at least one prior systemic therapy. The designation, announced by Eli Lilly and Company on August 3, 2026, marks […]

The FDA has accepted the NDA for daraxonrasib, a first-in-class oral RAS(ON) multi-selective inhibitor for previously treated metastatic pancreatic ductal adenocarcinoma. The application is supported by Phase 3 data demonstrating significant improvements in overall and progression-free survival.

The Phase 3 RASolute 302 trial has demonstrated that daraxonrasib, an oral RAS(ON) multi-selective inhibitor, nearly doubles overall survival compared to standard-of-care chemotherapy in patients with previously treated metastatic pancreatic adenocarcinoma (mPDAC). The study met all primary and key secondary endpoints, showing statistically significant and clinically meaningful improvements in both overall survival and progression-free survival […]

New data from an ongoing Phase 1/2 trial demonstrate remarkable efficacy for the combination of vopimetostat, an investigational PRMT5 inhibitor, and daraxonrasib, a RAS(ON) inhibitor, in patients with MTAP-deleted and KRAS-mutant metastatic pancreatic ductal adenocarcinoma (PDAC). The combination achieved a 92% objective response rate with encouraging durability signals, supporting advancement to Phase 3 development. Clinical […]

A novel AI model called REDMOD detected pancreatic ductal adenocarcinoma up to 3 years before clinical diagnosis using routine CT scans, achieving nearly double the sensitivity of expert radiologists. The technology could transform pancreatic cancer detection by identifying disease during its potentially curable, pre-symptomatic phase.

Daraxonrasib demonstrated a significant overall survival benefit versus standard-of-care chemotherapy in the Phase 3 RASolute 302 trial in previously treated metastatic pancreatic ductal adenocarcinoma, nearly doubling median OS (13.2 vs 6.7 months). The oral RAS(ON) inhibitor also improved progression-free survival and showed a manageable safety profile with no new safety signals. These findings support its potential as a new standard-of-care option and reinforce direct RAS inhibition as a clinically meaningful strategy in RAS-driven cancers.