Overview
- Daraxonrasib, an oral pill from Revolution Medicines, is now available to some patients through an FDA-authorized expanded access program while full approval is under review.
- Cancer centers say they are fielding a rush of requests and must route each case through physician applications and institutional review before treatment can begin.
- A late-phase study reported median overall survival of 13.2 months on daraxonrasib compared with 6.7 months on chemotherapy in previously treated metastatic pancreatic cancer.
- The drug uses a molecular “glue” to disable KRAS, a mutation that drives more than 90% of pancreatic cancers and was long considered undruggable.
- Doctors report frequent skin and gastrointestinal side effects and are required to monitor patients and report serious events, as the company works on an expedited FDA filing timeline.