Revolution Medicines Wins Orphan Drug Status

FDA has granted Revolution Medicines an orphan drug designation for its investigational therapy daraxonrasib (also known as RMC-6236) for treating pancreatic cancer. Daraxonrasib is currently being evaluated in a global Phase 3 study (RASolute 302) in patients with second-line metastatic pancreatic ductal adenocarcinoma (PDAC). The company says it plans to launch two additional Phase 3 trials in pancreatic cancer: one in first-line metastatic PDAC, and another in the adjuvant setting for patients with resectable disease.

Daraxonrasib is an oral drug designed to target active forms of RAS by inhibiting interaction with downstream effectors, according to the company. It is described as a “RAS(ON) multi-selective inhibitor,” capable of acting against RAS mutations such as G12X, G13X and Q61X — common drivers in cancers including PDAC, non-small cell lung cancer, and colorectal cancer.