FDA approves Revolution Medicines' Rasonque for pancreatic cancer
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The FDA approved Rasonque, a once-daily pill by Revolution Medicines, for adults with metastatic pancreatic adenocarcinoma who have received prior treatment. The drug targets RAS mutations and showed a median overall survival of 13.2 months versus 6.7 months on standard chemotherapy. The approval came 6.5 months ahead of the FDA's user-fee deadline.
Key Facts
- Rasonque is approved for adults with metastatic pancreatic adenocarcinoma who have already tried one round of treatment or cannot receive combination chemotherapy.
- In the pivotal trial, patients taking Rasonque lived a median of 13.2 months compared with 6.7 months on standard chemotherapy.
- Revolution Medicines set a list price of $39,800 for a 30-day supply of Rasonque.
- The FDA reviewed Rasonque under its National Priority Voucher pilot program, and the drug carries Breakthrough Therapy and Orphan Drug designations.
- An expanded access program opened in May has already reached more than 2,000 patients.
Approval Details
The FDA approved Rasonque on Wednesday for adults with metastatic pancreatic adenocarcinoma who have already tried one round of treatment or cannot receive combination chemotherapy. The drug does not require a test to identify a specific RAS mutation first. The application was reviewed under the FDA's National Priority Voucher pilot program, and the drug also carries Breakthrough Therapy and Orphan Drug designations. The decision came 6.5 months before the FDA's user-fee deadline, aided by new changes in the agency which let international regulators review oncology applications alongside the FDA.
Clinical Trial Results
In the trial that led to approval, patients with previously treated metastatic pancreatic adenocarcinoma who took Rasonque lived a median of 13.2 months, compared with 6.7 months on standard chemotherapy. Rasonque cut the risk of death by 60%, and patients went longer before their disease progressed and before pain and quality of life worsened. Brian Wolpin, the trial's principal investigator and director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute, said the approval "gives physicians the confidence that directly inhibiting RAS can make a striking difference for patients." Anna Berkenblit of the Pancreatic Cancer Action Network called it "the most significant advance we have seen in the fight against pancreatic cancer."
Market and Access
Revolution Medicines set a list price of $39,800 for a 30-day supply, with eligible insured patients paying as little as $0 through a new support program. An expanded access program opened in May has already reached more than 2,000 patients. The drug targets a mutation in the KRAS gene found in nearly all pancreatic cancers and many cases of lung, colorectal and ovarian cancer. Revolution Medicines is already advancing daraxonrasib through late-stage lung cancer trials.
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FDA approves Revolution Medicines' Rasonque for pancreatic cancer
