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After decades of failed attempts to drug the "undruggable" KRAS protein, daraxonrasib (Rasonque) has received FDA approval for metastatic pancreatic cancer — and the data are stunning. In the phase 3 RASolute 302 trial, patients lived a median of 13.2 months on the daily pill vs. 6.7 months on chemotherapy. With 79 RAS-targeting drugs now in 238 trials worldwide, this is just the beginning.
For decades, KRAS — the mutation driving more than 90% of pancreatic cancers — was considered "undruggable." Its smooth, pocket-free surface defeated every attempt to block it, and companies abandoned programs while patients ran out of options. That changed in August 2026, when the FDA approved daraxonrasib (Rasonque, Revolution Medicines), the first broad RAS-targeted therapy for metastatic pancreatic ductal adenocarcinoma (PDAC), for adults who have received at least one prior systemic therapy or are not candidates for multiagent chemotherapy.
The approval was built on the phase 3 RASolute 302 trial (n=500), which showed daraxonrasib — an oral, once-daily pan-RAS inhibitor that works by binding the chaperone protein cyclophilin A and locking RAS in its "off" state — nearly doubled overall survival vs. standard chemotherapy. The drug also tripled objective response rates and significantly delayed deterioration in both pain and quality of life. Discontinuation due to adverse events was rare with daraxonrasib (1.2%) compared to chemotherapy (11.2%), though rash and stomatitis remain key management challenges. The FDA also granted breakthrough therapy designation to daraxonrasib plus gemcitabine/nab-paclitaxel for first-line PDAC, and at least 79 RAS-targeting drugs are now in 238 clinical trials worldwide.
By the Numbers:
Why it matters: Pancreatic cancer has long been one of oncology's most stubborn foes, with second-line chemotherapy offering only ~6 months of survival. Daraxonrasib's approval marks the first time a targeted therapy has meaningfully moved the needle in this disease — and with dozens more RAS inhibitors in the pipeline, it signals the dawn of a new treatment era for one of cancer's deadliest diagnoses.