Revolution Medicines gains FDA Breakthrough Therapy status for RASONQUE
Revolution Medicines has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for RASONQUE (daraxonrasib) in previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC).
The designation covers RASONQUE in combination with gemcitabine and nab-paclitaxel (GnP), a multi-agent chemotherapy regimen commonly used to treat PDAC.
The combination is being evaluated in patients who have not previously received systemic treatment for metastatic disease.
The FDA designation is based on preliminary results from the Phase 1/2 RMC-GI-102 study.
In patients with RAS-mutant metastatic PDAC, RASONQUE combined with GnP showed early anti-tumour activity and a manageable safety profile.
The findings are supporting the ongoing Phase 3 RASolute 303 trial, which is evaluating RASONQUE as a single treatment and in combination with GnP against GnP alone in patients with previously untreated metastatic PDAC.
The study includes patients regardless of their tumour RAS genotype.
RASONQUE is already FDA-approved for adults with metastatic PDAC who have received at least one previous systemic therapy or who are not candidates for multi-agent systemic treatment.
The combination of RASONQUE with chemotherapy for previously untreated metastatic PDAC remains investigational, and its safety and efficacy have not yet been established.
The Breakthrough Therapy designation is intended to support faster development and review of medicines addressing serious conditions and significant unmet medical needs.
