Health
FDA approves daraxonrasib for advanced pancreatic cancer
The daily pill by Revolution Medicines targets mutated RAS proteins, doubling median survival times in clinical trials.
The short version
- The FDA granted expedited approval to daraxonrasib (brand name Rasonque), a daily oral medication for the most common form of advanced pancreatic cancer.
- In a company-funded clinical study, patients taking the medication achieved a median overall survival of 13.2 months compared to 6.7 months for those on chemotherapy.
- The therapy works by targeting mutated proteins in the RAS gene family that fuel tumor growth in over 90% of pancreatic cancer cases.
- The approval arrived more than six months ahead of the FDA's original target date.
Key facts
- The FDA approved daraxonrasib, developed by California-based Revolution Medicines, as a second-line treatment for advanced pancreatic cancer.[STAT · Associated Press]
- In a trial of 500 patients whose metastatic cancer stopped responding to earlier treatments, median overall survival was 13.2 months with daraxonrasib versus 6.7 months with chemotherapy.[STAT · Associated Press]
- The drug targets KRAS mutations and broader RAS gene family alterations, utilizing a molecular mechanism to bind to mutated proteins.[STAT · Associated Press]
- The American Cancer Society projects roughly 67,000 new pancreatic cancer diagnoses and over 52,000 deaths in the U.S. this year, with a five-year overall survival rate of 13%.[Associated Press]
- The FDA granted approval more than six months ahead of its regulatory target date.[Associated Press]
What remains uncertain
- The effectiveness of the drug's underlying technology across other cancer types, such as lung cancer, remains under ongoing study.[Associated Press]