The US Food and Drug Administration granted expedited approval to daraxonrasib, a first-of-its-kind pill for the most common form of pancreatic cancer, developer Revolution Medicines said on Wednesday. The drug targets a disease long regarded as among the deadliest cancers.
Daraxonrasib blocks a mutated RAS protein that drives tumor growth in more than 90% of pancreatic cancer cases. The approach had eluded drugmakers for decades, with the protein once considered too difficult to target directly.
The accelerated approval clears the treatment for patients with pancreatic ductal adenocarcinoma, the most prevalent variant. Regulators use the expedited pathway for therapies that address serious conditions and fill an unmet medical need, allowing earlier market access ahead of confirmatory trial data.
Pancreatic cancer carries one of the lowest survival rates of any major cancer, in part because it is often detected after it has spread. Existing chemotherapy options offer limited benefit, leaving few effective treatments for advanced disease.
The RAS family of mutations fuels a wide range of tumors beyond the pancreas. Efforts to disable the protein have advanced steadily in recent years, including therapies aimed at the KRAS-G12C mutation in lung, colorectal, and pancreatic cancers.
Revolution Medicines has positioned daraxonrasib as a broader RAS inhibitor rather than one confined to a single mutation subtype. That design could extend its potential use across other RAS-driven tumors if further trials confirm the benefit.
Under accelerated approval rules, the company must complete additional studies verifying the drug’s clinical benefit. Should those trials fail to confirm the results, the FDA can withdraw the clearance.