FDA approves Revolution Medicines' Rasonque for pancreatic cancer at $39,800 monthly list price
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The FDA approved Revolution Medicines' oral tablet daraxonrasib, branded Rasonque, for adults with metastatic pancreatic adenocarcinoma. In phase 3 trials, the drug reduced the risk of death by 60% and extended median survival to 13.2 months versus 6.7 months on chemotherapy. The approval comes with a wholesale acquisition cost of approximately $39,800 per 30-day supply, or about $477,000 per year.
Key Facts
- Rasonque reduced the risk of death by 60% in phase 3 trials, with median survival of 13.2 months versus 6.7 months on chemotherapy.
- The wholesale acquisition cost is approximately $39,800 for a 30-day supply, or about $477,000 per year, more than double the list price of Merck's Keytruda.
- The FDA approved Rasonque 35 days after accepting Revolution Medicines' application, citing it as a critical new option for a historically hard-to-treat cancer.
- Revolution Medicines CFO Jack Anders said Medicare Part D coverage and government discounts could lower the price by an estimated 20% to 30%.
- Pancreatic cancer is the third-leading cause of cancer death in the U.S., behind lung and colorectal cancers, according to the American Cancer Society.
Clinical Trial Results
In phase 3 trials, patients receiving Rasonque lived a median of 13.2 months, compared with 6.7 months for those on chemotherapy. The drug reduced the risk of death by 60% in the same trial population. Rasonque is approved for adults with metastatic pancreatic adenocarcinoma (PDAC), a common form of pancreatic cancer. The FDA noted the most common side effects as rash, diarrhea, inflammation of the mouth's mucous membranes, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.
Pricing and Patient Access
Revolution Medicines set a wholesale acquisition cost of approximately $39,800 for a 30-day supply at the recommended daily dose, or about $477,000 per year. BioPharma Dive reported that this list price is more than double that of Merck's Keytruda, the top-selling cancer medication. On the investor conference call announcing the FDA approval, CFO Jack Anders said some eligible patients would be covered by Medicare Part D, with additional government discounts lowering the price by an estimated 20% to 30%. Revolution Medicines' ONPath program states it can help patients find resources to start treatment, and the investor presentation noted the drug could be purchased with as little as $0 co-pay for eligible commercially insured patients.
Regulatory and Expert Response
The FDA approved Rasonque 35 days after accepting Revolution Medicines' application, describing it as a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer. Anna Berkenblit, M.D., chief scientific and medical officer for the Pancreatic Cancer Action Network (PanCAN), called the FDA's approval the most significant advance in the fight against pancreatic cancer. Pancreatic cancer is the third-leading cause of cancer death in the U.S., behind lung and colorectal cancers, according to the American Cancer Society.
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FDA approves Revolution Medicines' Rasonque for pancreatic cancer at $39,800 monthly list price
