FDA Approves Revolution Medicines’ Breakthrough Therapy Daraxonrasib for Pancreatic Cancer
Revolution Medicines has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to daraxonrasib. This investigational treatment targets previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) in patients with KRAS G12 mutations.
The designation follows promising data from the Phase 1 RMC-6236-001 clinical trial, which evaluated daraxonrasib in patients with advanced PDAC.
Breakthrough Therapy Designation is intended to speed up the development and review of drugs that treat serious or life-threatening conditions and show early clinical evidence of significant benefit over existing therapies.
Daraxonrasib is a direct, oral RAS (ON) multi-selective inhibitor designed to block key cancer-driving RAS mutations, including G12X, G13X and Q61X.
These mutations are known to drive tumour growth in several cancers such as PDAC, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC).
Revolution Medicines is currently enrolling participants in its global Phase 3 registrational trial, RASolute 302, which is focused on previously treated metastatic PDAC
The primary goals of the study are to evaluate progression-free survival (PFS) and overall survival (OS) in the core patient group, with secondary goals including PFS and OS in the broader patient population.
Revolution Medicines aims to complete most of the RASolute 302 trial enrolment in 2025, with results expected in 2026. If outcomes are positive, the company intends to work closely with regulatory bodies to make daraxonrasib available to patients as quickly as possible.
