Timeline
From first-in-human study to FDA approval: key milestones for daraxonrasib
NEJM publishes Phase 1/2 NSCLC data
The New England Journal of Medicine publishes Phase 1/2 results of daraxonrasib in previously treated RAS-mutant NSCLC: ORR 42%, median PFS 8.3 months, median OS 16 months.
FDA approves RASONQUE
The FDA approves daraxonrasib (RASONQUE) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multi-agent systemic therapy — the first approved RAS-targeted therapy for pancreatic cancer.
FDA accepts the New Drug Application (NDA)
Revolution Medicines announces FDA acceptance of the daraxonrasib NDA for previously treated metastatic pancreatic cancer under Real-Time Oncology Review (RTOR).
ASCO 2026 Plenary presentation and NEJM publication
Prof. Brian M. Wolpin presents the full RASolute 302 results at the ASCO Plenary (LBA5): median OS 13.2 vs 6.7 months, HR 0.40.
Positive topline results from RASolute 302
The trial meets its primary and key secondary endpoints: overall and progression-free survival significantly improved, with a manageable safety profile and no new safety signals.
FDA National Priority Voucher (CNPV) awarded
Daraxonrasib is among the first recipients of the FDA's Commissioner's National Priority Voucher pilot, enabling a 1–2 month review.
FDA grants Breakthrough Therapy Designation
The FDA grants daraxonrasib Breakthrough Therapy Designation for previously treated metastatic pancreatic ductal adenocarcinoma with KRAS G12 mutations.
First patient dosed in RASolve 301
The Phase 3 trial in previously treated RAS-mutant non-small cell lung cancer (vs docetaxel) begins.
RASolute 303 and RASolute 304 launched
The Phase 3 registrational trials in first-line metastatic pancreatic cancer (303) and the adjuvant setting (304) enroll their first patients.
First patient dosed in RASolute 302
The registrational Phase 3 trial RASolute 302 begins, comparing daraxonrasib with standard chemotherapy in previously treated metastatic pancreatic cancer.
Updated pancreatic cancer cohort data at ESMO 2024
Progression-free and overall survival in previously treated metastatic pancreatic cancer clearly exceed historical controls, laying the groundwork for Phase 3.
First Phase 1 clinical data presented
Initial safety and antitumor activity data for RMC-6236 in NSCLC and PDAC are presented at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference.
First-in-human study RMC-6236-001 begins
Revolution Medicines starts the Phase 1/2 first-in-human study of RMC-6236 in patients with advanced RAS-mutant solid tumors (NCT05379985).