Key facts
- The FDA approved Revolution Medicines' Rasonque (daraxonrasib) for adults with metastatic pancreatic cancer.
- Rasonque is a first-in-class oral pill that blocks mutated RAS proteins fueling tumor growth in over 90% of pancreatic cancer cases.
- In a study, patients on Rasonque lived a median of 13.2 months, nearly double the 6.7 months seen with standard chemotherapy.
- The drug targets a specific genetic cause of pancreatic cancer, a disease with a low five-year survival rate of 13%.
- The FDA granted expedited approval for Rasonque, more than six months ahead of its target date.
The U.S. Food and Drug Administration has approved Revolution Medicines' targeted drug, Rasonque (daraxonrasib), for adults with metastatic pancreatic cancer who have previously undergone treatment or cannot receive combination chemotherapy. This approval marks a significant advancement for a disease with a historically low five-year survival rate of approximately 13%.
Rasonque is a once-daily oral pill designed to block several forms of the RAS protein, a key driver of tumor growth in many pancreatic cancers. It is considered a first-in-class therapy targeting a specific genetic cause of the disease. The drug's approval was based on a study involving 500 adults with previously treated metastatic pancreatic adenocarcinoma, the most common form of the cancer.
In the study, patients treated with Rasonque experienced a median overall survival of 13.2 months, nearly doubling the 6.7 months seen with standard chemotherapy. The drug was also included in the FDA Commissioner's National Priority Voucher program, which accelerates reviews for therapies addressing critical U.S. health priorities and unmet medical needs. Common side effects reported included rash, diarrhea, nausea, and fatigue.