Rasonque (Daraxonrasib) Wins FDA Breakthrough Therapy Designation for First-Line Pancreatic Cancer
On September 14, 2026, Revolution Medicines announced the FDA granted breakthrough therapy designation (BTD) to Rasonque (daraxonrasib) in combination with gemcitabine and nab-paclitaxel chemotherapy for first-line metastatic pancreatic adenocarcinoma (mPDAC) — extending the story of the RAS(ON) G12C inhibitor approved August 26 as the first targeted therapy for metastatic pancreatic cancer (see Rasonque (Daraxonrasib) Wins FDA Breakthrough Therapy Designation for First-Line Pancreatic Cancer).
The designation rests on early combination data from the Phase 1/2 RASolute trial: "Confirmed ORR reached 58% (1 CR) in 40 patients, with encouraging estimated 6-month PFS (84%) and OS (90%) despite immature time-to-event endpoints." The combination is now being tested in a global Phase 3 trial in first-line mPDAC. Safety from the label of the monotherapy approval is sobering — dermatologic toxicity 86%, diarrhea 63%, stomatitis 57%, plus GI perforation (0.9%, including one fatal event) and ILD/pneumonitis (2.4%, one fatal) — which is why the first-line combination's Phase 3 tolerability data will be decisive.
BTD means FDA organizational commitment and senior-agency involvement — a signal the agency sees the first-line combination data as potentially practice-changing in a disease with a ~13% five-year survival rate.