The US Food and Drug Administration (FDA) has approved Rasonque, marketed as daraxonrasib by Revolution Medicines, for treating advanced pancreatic cancer. The once-daily pill targets mutated RAS proteins present in over 90% of pancreatic cancer cases, offering a significant advancement against one of the deadliest cancers.
Key Takeaways
The US Food and Drug Administration (FDA) has approved Rasonque, marketed as daraxonrasib by Revolution Medicines, for treating advanced pancreatic cancer. This once-daily pill targets mutated RAS proteins present in over 90% of cases, significantly improving survival rates.
- FDA expedited approval based on a clinical trial showing median survival of 13.2 months vs. 6.7 months with chemotherapy
- Rasonque uses molecular glue technology to bind with multiple KRAS subtypes
- Side effects include skin rash, mouth sores, and digestive issues
- The drug costs approximately $39,800 for a one-month supply
- American Cancer Society estimates about 67,000 new cases will be diagnosed this year
Source Claims Check
High Consensus| Claim | Status | Reason | |
|---|---|---|---|
| Survival Rate With Rasonque | Broad Agreement | 13.2 months median survival for patients taking Rasonque | |
| Survival Rate With Chemotherapy | Broad Agreement | 6.7 months median survival for patients receiving standard chemotherapy | |
| Percentage Of Pancreatic Cancer Cases With Ras Mutations | Broad Agreement | Over 90% of pancreatic cancer cases have RAS mutations | |
| Side Effects Of Rasonque | Broad Agreement | Skin rash, mouth sores, diarrhea and other digestive issues | |
| Cost Of One-month Supply Of Rasonque | Broad Agreement | $39,800 for a one-month supply |
The FDA granted expedited approval based on a clinical trial involving 500 patients with metastatic pancreatic adenocarcinoma who had received prior treatment or could not undergo combination chemotherapy. Patients taking Rasonque lived for a median of 13.2 months, compared to 6.7 months for those receiving standard chemotherapy.
The approval marks a milestone in treating pancreatic cancer, which has a low five-year survival rate of about 13%. FDA acting commissioner Kyle Diamantas emphasized the agency's commitment to delivering meaningful treatments swiftly. Doctors have expressed optimism that this approval could pave the way for more innovative treatment options in the future.
Rasonque uses molecular glue technology to bind with multiple KRAS subtypes, addressing mutations in the Ras gene family previously considered 'undruggable'. The company is also exploring its technology for other forms of cancer, including lung cancer. The FDA's expedited review process was facilitated by the Commissioner's National Priority Voucher program.
According to HuffPost and UPI, side effects included skin rash, mouth sores, diarrhea and other digestive issues. A one-month supply of Rasonque would cost approximately $39,800, as announced by Revolution Medicines. The American Cancer Society estimates about 67,000 new cases will be diagnosed this year with more than 52,000 deaths expected.
The drug garnered public attention earlier this year when former Sen. Ben Sasse described on CBS' '60 Minutes' how he had less pain while taking it, leading the FDA to allow expanded access for certain patients before official approval. The FDA approved the drug more than six months ahead of their target date.
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