Feuerstein discusses daraxonrasib mechanism and trial results

NPR’s A Martinez spoke with STAT science and health reporter Adam Feuerstein about the FDA’s recent approval of a new drug to treat pancreatic cancer. The interview, published Thursday by the public broadcaster, focused on a treatment NPR characterized as a breakthrough in care for one of the deadliest forms of cancer.

The FDA on Wednesday granted expedited approval to daraxonrasib, a once-daily pill developed by Revolution Medicines of Redwood City, California. The drug, to be sold under the brand name Rasonque, is the first therapy approved to directly target mutated KRAS proteins that fuel tumor growth in more than 90% of pancreatic cancer cases, according to the FDA and reporting by STAT and the Associated Press.

Daraxonrasib uses what Revolution Medicines describes as a molecular glue to bind with multiple KRAS subtypes simultaneously, an approach that had eluded drugmakers since the mutation’s role in cancer was first understood. The approval covers the most common form of pancreatic cancer.

The approval was supported by a company-funded trial that randomly assigned 500 patients with metastatic pancreatic cancer that had stopped responding to prior treatment. Patients who received daraxonrasib lived a median of 13.2 months, compared with 6.7 months for those who received additional chemotherapy, and experienced fewer severe side effects, according to the study.

The agency approved the drug more than six months ahead of its target date. “It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible,” FDA acting commissioner Kyle Diamantas said in a statement.

Pancreatic cancer remains among the deadliest common cancers, in part because it is difficult to detect before it spreads to other organs. The American Cancer Society estimates that roughly 67,000 new cases will be diagnosed in the United States this year and that more than 52,000 people will die from the disease. The five-year overall survival rate stands at 13%.

Revolution Medicines is studying the same molecular-glue technology against other cancers, including lung cancer, where KRAS mutations also play a significant role.

The drug drew broader public attention earlier this year when former U.S. Senator Ben Sasse of Nebraska described on CBS’s “60 Minutes” program how he had experienced less pain while taking it. The surge in interest led the FDA to allow expanded access, making the drug available before official approval to patients who met certain criteria.

Doctors who treat pancreatic cancer have expressed optimism that the approval could open the door to additional treatment options. Unlike with other cancers that have benefited from multiple chemotherapy alternatives, pancreatic cancer has been harder to tackle, and dozens of experimental drugs are now in development, according to The Guardian.

NPR noted in its coverage that it does not offer or accept money for coverage or interviews and that anyone who makes such an offer or request is not an NPR employee and does not represent the broadcaster.

MSI previously reported on Wednesday’s FDA approval of daraxonrasib, with coverage in FDA approves Rasonque, first-of-a-kind pill for pancreatic cancer and FDA approves first KRAS-targeted pill for pancreatic cancer.