Daraxonrasib (RMC-6236) has been accepted by the FDA for review as a treatment for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The oral drug targets multiple RAS mutations, which are found in more than 90% of PDAC tumors. The application is being reviewed through the FDA Commissioner’s National Priority Voucher pilot program, which could shorten the review time to 1–2 months.
The phase 3 RASolute 302 trial enrolled 500 patients whose cancer had progressed after one prior treatment. Daraxonrasib improved median overall survival to 13.2 months, compared with 6.7 months for chemotherapy. It also doubled progression-free survival, increased the response rate to 31.6% versus 11.2%, and delayed worsening of cancer-related pain.
The drug was generally well tolerated, with fewer serious treatment-related side effects than chemotherapy. The most common side effects were rash, diarrhea, mouth sores, nausea, and vomiting, and most were mild to moderate.