The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Revolution Medicines Inc.'s (NASDAQ: RVMD) RASONQUE (daraxonrasib) for the treatment of treatment-naïve metastatic pancreatic adenocarcinoma in combination with gemcitabine and nab-paclitaxel. This marks the third Breakthrough Therapy Designation for RASONQUE and the fifth across Revolution Medicines' portfolio of RAS(ON) inhibitors.
The designation is based on data from the Phase 1/2 RMC-GI-102 trial, which evaluated RASONQUE combined with gemcitabine and nab-paclitaxel in patients with treatment-naïve RAS mutant metastatic pancreatic adenocarcinoma. The combination showed preliminary antitumor activity and a manageable safety profile consistent with the known safety profiles of both RASONQUE and the chemotherapy regimen. The data informed the design of RASolute 303, an ongoing global Phase 3 trial evaluating RASONQUE as a monotherapy and in combination with gemcitabine and nab-paclitaxel versus the chemotherapy regimen alone in patients with previously untreated metastatic pancreatic adenocarcinoma.
Pancreatic adenocarcinoma is a significant health concern in the U.S., with approximately 55,000 new cases diagnosed each year and more than 50,000 deaths annually. About 80% of patients are diagnosed after the disease has spread, and the 5-year relative survival rate for metastatic pancreatic adenocarcinoma is approximately 3%. The combination use of RASONQUE with chemotherapy for treatment-naïve metastatic pancreatic adenocarcinoma remains investigational, with safety and efficacy not yet established.
