US Cancer Centers Report Surge in Requests for Experimental Pancreatic Cancer Drug

US cancer centers are grappling with an influx of patient requests for the experimental pancreatic cancer drug daraxonrasib after the developer reported promising clinical trial results. The FDA approved an expanded access program for the drug on 1 May, three weeks after the company announced that its once-daily pill had doubled survival rates in a trial for patients with advanced pancreatic cancer.

This form of cancer is known for its aggressive nature and one of the lowest five-year survival rates. The company had sought permission from the FDA to provide the drug free of charge to patients with previously treated metastatic pancreatic cancer.

A medical oncologist at the Zuckerberg Cancer Center of Northwell Health said the public learned of the FDA announcement, which triggered a large number of patient requests. Oncologists have said that establishing and managing the program requires significant time and resources beyond normal operations.

The drug targets a genetic mutation present in approximately 90 percent of pancreatic cancers.

In the clinical trial, daraxonrasib extended median survival to 13.2 months compared with 6.7 months for patients who received standard chemotherapy. A co-director of the pancreas center at Columbia/New York-Presbyterian said doubling survival compared with the best available chemotherapy is a significant result.

The same physician noted that in a decade-long career only one other experimental drug had prompted a compassionate use request, but seven patients inquired about daraxonrasib in a single recent day. A pancreas cancer specialist at City of Hope said patients are already aware of the press release and have begun calling clinics.

Gaining access to the drug is more complex than obtaining a prescription for an approved medication. Physicians must submit individual patient requests to the company. If the company deems a patient suitable, the request is forwarded to the FDA and hospital monitoring boards oversee the patients.

One specialist expressed uncertainty about how the FDA would handle a large volume of applications and suggested the agency might create a general enrollment protocol. Centers are not required to collect detailed data but must report serious side effects.

Daraxonrasib was among the first products accepted into the FDA's new expedited review process last year. This could lead to approval within one to two months of a complete application submission. The company, based in Redwood City, California, did not respond to a request for comment.

" The FDA did not respond to a request for comment on the program. The American Cancer Society estimates that about 67,000 people in the United States will be diagnosed with pancreatic cancer this year, and 53,000 will die from it. One specialist said the centers are providing the program as a service to patients.