The FDA has granted expedited approval to Rasonque, a new daily pill for advanced pancreatic cancer that has shown promise in extending survival times for patients.
Key facts
- •Rasonque is the first-of-a-kind pill approved to block mutated proteins fueling over 90% of pancreatic cancer cases.
- •Patients in the study saw their median survival time increase from 6.7 months with chemotherapy to 13.2 months with the new drug.
- •The drug is manufactured by Redwood City-based Revolution Medicines and carries a monthly cost of approximately $39,800.
- •The FDA approved the treatment more than six months ahead of its target date.
- •The five-year overall survival rate for pancreatic cancer is currently 13%.
The U.S. Food and Drug Administration on Wednesday granted expedited approval to Rasonque, a new pill developed by Revolution Medicines for advanced pancreatic cancer. The drug, known as daraxonrasib, is designed to block a mutated protein that fuels tumor growth in over 90% of pancreatic cancer cases. Regulators approved the treatment more than six months ahead of their original target date.
By the numbers
Clinical Trial Results and Efficacy
In a company-funded study involving 500 patients with metastatic cancer that had stopped responding to prior treatments, those receiving the new drug experienced a median survival time of 13.2 months. This compared to 6.7 months for patients who received additional chemotherapy. While the drug is not considered a cure, medical experts highlighted it as a significant improvement in treatment options. Reported side effects include skin rashes, mouth sores, and digestive issues like diarrhea.
Targeting 'Undruggable' Mutations
The drug functions by using molecular glue to bind with multiple KRAS subtypes, which are mutations in the RAS gene family that regulate cell growth. These mutations were long considered 'undruggable' due to a structure that prevented drugs from effectively sticking to the proteins. The approval of this technology is expected to influence future research, with doctors noting that it may open doors for trials involving other tumor types, including lung cancer.
Public Access and Cost
Revolution Medicines announced that a one-month supply of the daily pill will cost approximately $39,800. Public interest in the drug grew earlier this year after former Senator Ben Sasse shared his experience with the treatment on '60 Minutes,' leading the FDA to grant expanded access to certain patients prior to full approval. Pancreatic cancer remains highly lethal, with the American Cancer Society estimating 67,000 new diagnoses and 52,000 deaths in the United States this year.
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This article was independently rewritten by ManyPress editorial AI from reporting originally published by NPR Health.
