Breakthrough pancreatic cancer drug sparks huge patient demand at US clinics

Key Points:

• US cancer centers face a surge in patient requests for daraxonrasib, an experimental pancreatic cancer drug, following the FDA's approval of an expanded access program on May 1, shortly after the drug showed doubled survival rates in clinical trials.
• Daraxonrasib targets a genetic mutation in about 90% of pancreatic cancers and extended median survival to 13.2 months compared to 6.7 months with standard chemotherapy, marking a significant breakthrough in treatment.
• Oncologists report that managing the early access program is resource-intensive, requiring individual patient requests to be approved by Revolution Medicines and the FDA, with hospital monitoring boards overseeing treatment.
• The FDA's expedited review process could lead to full approval within one to two months after a complete application, but concerns remain about handling the potentially high volume of access requests.
• Pancreatic cancer remains highly lethal, with an estimated 67,000 new US cases and 53,000 deaths expected this year, underscoring the urgent need for effective treatments like daraxonrasib.