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Breakthrough Pancreatic Cancer Drug Rasonque Approved, Raises Hopes and Access Challenges
Confirmed
In Short: The FDA approved Rasonque, a new pancreatic cancer drug that significantly extended median survival in clinical trials, marking a milestone in a notoriously difficult-to-treat disease.
Revolution, the company behind Rasonque, announced that the drug extended median survival to 13.2 months in a Phase 3 trial, compared to 6.7 months for those on chemotherapy. This marked the first time any patients with pancreatic cancer lived more than a year after receiving an experimental drug treatment in a clinical trial, according to Revolution's chief development officer Alan Sandler.
The approval, just a month after a completed submission, represents a significant shift in the treatment landscape for pancreatic cancer. European regulators are also evaluating the therapy for potential approval. Analysts predict a lucrative market for Rasonque, with premium pricing expected to support high peak revenue estimates.
However, the transition from early access programs to commercial insurance coverage can be challenging. As of early August, over 2,000 people had received Rasonque under compassionate use. But for many patients, the process of obtaining insurance coverage can take weeks or months, creating delays in accessing the drug.
‘Unfortunately, we have heard from some patients who are caught in this transition,’ said Julie Fleshman, the president and CEO of the Pancreatic Cancer Action Network, PanCAN. Kelsey Solano, a patient who received Rasonque through compassionate use, shared her experience: ‘Got through it. Ended up doing really well. Finished off FOLFIRINOX.’ Despite the drug's success, the transition to commercial coverage remains a hurdle for many patients.
What's confirmed
What's still developing
- “This drug showed unprecedented results in an area of high unmet need,” said Angelo de Claro, director of the FDA’s Oncology Center of Excellence, in a statement.
- Clearance in the U.S. starts what’s expected to be a lucrative drug launch.
- “Given the impressive data and unmet need, the market could likely support premium pricing, enabling even higher peak revenue estimates as the drug ultimately moves to other indications and larger tumors,” Timashev wrote in a Wednesday client note.
- Prior to its clearance, a couple other drugs targeting a specific type of “KRAS” mutation made it to market.
- When the Food and Drug Administration approved a new pancreatic cancer drug called Rasonque last month, researchers and patient advocates celebrated.
- But for patients who are in the process of getting expanded access — often called compassionate use — they can turn what is meant to be a straightforward process into a labyrinth.
- The problem, Solano and cancer experts told STAT, is that regulatory approvals trigger the closure of early access programs, but commercial insurance coverage often isn’t available for weeks or months as payers work through the technical steps required to begin covering a new medication.
- Juan went back into treatment and started a clinical trial at the Fred Hutchinson Cancer Center in Seattle, nearly four hours from Pasco, Wash., where the couple lives.