Regulatory decisions, clinical data, congress presentations and company updates
On August 26, 2026 the U.S. FDA approved 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 RAS-targeted therapy approved for pancreatic cancer.
Source: U.S. FDA
Revolution Medicines announced that the FDA accepted the daraxonrasib NDA under Real-Time Oncology Review; with a National Priority Voucher, the review period is expected to be dramatically shortened.
Source: Revolution Medicines
Daraxonrasib is among the first recipients of the FDA Commissioner's National Priority Voucher (CNPV) pilot, allowing a 1–2 month review once a marketing application is submitted.
Source: Inside Precision Medicine
The FDA granted daraxonrasib Breakthrough Therapy Designation for previously treated patients with metastatic pancreatic ductal adenocarcinoma harbouring KRAS G12 mutations.
Source: Revolution Medicines
