An experimental drug set to change the landscape of pancreatic cancer treatment has officially just become medical reality.
On Wednesday, the Food and Drug Administration approved Revolution Medicines’ daraxonrasib as a last resort option for adults with metastatic pancreatic adenocarcinoma (PDAC). In late-stage clinical trials, the drug doubled people’s length of survival compared to standard chemotherapy. Daraxonrasib, which will be sold under the brand name Rasonque, is poised to be the first in a new class of medications that can attack a long-elusive target commonly found in pancreatic and other cancers.
“Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer. It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible,” said Acting FDA Commissioner Kyle Diamantas in a statement from the agency.
The game-changer
The unrelenting growth of cancer cells can be driven by many different factors. That said, the vast majority of pancreatic cancers, perhaps up to 90%, are fueled by mutations in a particular family of proteins known as RAS. For years, scientists have tried and failed to find drugs that can block RAS in cancers—until now, that is. Daraxonrasib is designed to broadly inhibit many RAS variants at once, in theory allowing it to tackle a wide range of pancreatic cancers.
The FDA approved the drug on the basis of the company’s RASolute 302 trial, which involved roughly 500 patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). PDAC is the most common form of pancreatic cancer. Half were randomized to receive standard care (a mix of various chemotherapy drugs), and half received a daily dose of daraxonrasib. The trial included people with or without RAS-associated tumors.
The drug was a clear success. Overall, daraxonrasib reduced people’s risk of death by 60% compared to chemotherapy. The median length of survival for people on daraxonrasib was 13.2 months, compared to 6.7 months for people on chemotherapy. Those treated with the drug also lived longer without any signs of cancer progression (7.2 months vs. 3.6 months). Additionally, it appeared to be generally well-tolerated, with no unexpected safety signals.
What this means
Compared to many other kinds of cancer, we’ve struggled to find effective options for advanced pancreatic cancer. Currently, the five-year survival rate of pancreatic cancer is still only around 13%. So while these improvements might seem modest at first glance, there’s reason to hope that daraxonrasib and similar drugs can herald a new era of treatment for not only pancreatic cancer but also other cancers associated with RAS. The FDA, citing the unmet need for such drugs, notably approved daraxonrasib more than six months before its scheduled deadline for a decision.
For now, daraxonrasib will be approved for people with metastatic PDAC who have taken at least one prior systemic therapy or who aren’t able to undergo multiagent systemic therapy. But it’s certainly possible that RAS inhibitors could eventually become a first-line treatment for these types of cancers, either alone or in conjunction with other treatments, which could further improve outcomes.
This is undoubtedly the best news in the cancer field we’ve had in a while. And it might only be the start of something truly remarkable.
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