New drug nearly doubles life expectancy for pancreatic cancer but causes serious side effects

A Phase 3 trial found daraxonrasib extended median survival to 13.2 months versus 6.7 months with chemotherapy for metastatic pancreatic ductal adenocarcinoma, and former Sen. Ben Sasse reports severe skin-related side effects while taking the experimental drug outside that trial.

An experimental drug from Revolution Medicines, daraxonrasib, produced substantially longer median survival than standard chemotherapy in a Phase 3 trial for metastatic pancreatic ductal adenocarcinoma. The disease is often detected at an advanced stage and has few effective options. Former Sen. Ben Sasse, who is receiving daraxonrasib in a separate clinical setting, reported significant skin-related side effects while also saying the treatment has reduced his tumor burden and eased pain. RevMed plans to submit the Phase 3 results to the FDA and has an expedited review designation for the application. Key points: - Phase 3 trial: more than 500 patients with metastatic PDAC were randomized; median overall survival was 13.2 months on daraxonrasib versus 6.7 months on standard chemotherapy. - Mechanism: daraxonrasib targets mutated KRAS proteins and is reported to act across multiple KRAS variants, potentially extending its applicability beyond pancreatic cancer. - Safety and patient reports: RevMed described the trial safety profile as generally well tolerated and manageable; an individual receiving the drug in a separate treatment setting reported severe skin-related effects and bleeding alongside tumor reduction and pain improvement. - Regulatory and disease context: RevMed plans an FDA submission seeking second-line approval and received a Commissioner’s National Priority Voucher to expedite review; metastatic PDAC is often diagnosed late, about 90% of such tumors carry RAS mutations, and five-year survival remains low. Summary: The Phase 3 results indicate a notable survival difference for daraxonrasib versus chemotherapy in metastatic PDAC, while individual patient reports underscore variability in side-effect severity. RevMed intends to submit these trial results to the FDA and has an expedited review pathway; further regulatory review and ongoing studies will determine how and when the drug may become available.