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FDA granted "expanded access" to a promising new drug for pancreatic cancer, allowing a wider population of patients to receive the treatment while it is still under regulatory review, in today's bite-sized hospital and health industry news from the District of Columbia, Illinois, and Maryland.
- District of Columbia: At a recent American Hospital Association meeting, FBI deputy director Andrew Bailey called for hospital executives to increase their information sharing on cyberthreats to help the agency disrupt cyberattacks earlier. According to FBI statistics, healthcare was the top target for ransomware and other cyberthreats in 2025, which cost health systems millions per incident. Some major healthcare organizations affected by cyberattacks last year were Yale New Haven Health System and DaVita. "We're at a point where they're attacking a hospital system and it's just normal, everyday routine transactions for these groups," Bailey said. "For the hospital on the receiving end ... it's anything but." He emphasized the need to disrupt criminal networks behind these attacks and called for close coordination with hospitals to share threat intelligence and potentially identify attacks sooner. (Reed, Axios, 4/21)
- Illinois: The Americal Medical Association (AMA) has called on federal lawmakers to enact safeguards on AI chatbots, particularly those used for mental healthcare. "AI-enabled tools may help expand access to mental health resources and support innovation in healthcare delivery, but they lack consistent safeguards against serious risks, including emotional dependency, misinformation, and inadequate crisis response," said AMA CEO John Whyte in a news release. "With thoughtful oversight and accountability, policymakers can support innovation and ensure technologies prioritize patient safety, strengthen public trust, and responsibly complement — not replace — clinical care." Some of AMA's recommendations include requiring chatbots to clearly disclose to users that they are interacting with AI, prohibiting chatbots from presenting themselves as licensed clinicians, banning chatbots from diagnosing or treating mental health conditions without regulatory due diligence, and requiring strict standards for data protection. (Bruce, Becker's Health IT, 4/22)
- Maryland: FDA recently granted "expanded access" to a promising new drug for pancreatic cancer, allowing more patients to receive the treatment while it's still under regulatory review. The drug, which is called daraxonrasib and manufactured by Revolution Medicines, was able to almost double the length of survival for patients with pancreatic cancer in a phase 3 clinical trial. Patients who received daraxonrasib had a median overall survival of 13.2 months compared to 6.7 months for those who received chemotherapy. Because the drug is still being tested, it is only available to patients in clinical trials, which have limited slots. To allow more patients to receive the drug while it is still under regulatory review, Revolution requested FDA to grant the drug expanded access, which was quickly granted. "Granting the request two days after receiving the expanded access application reflects the FDA's strong commitment to facilitate early access to therapies for serious and life-threatening conditions, including pancreatic cancer," said FDA Commissioner Marty Makary. "Having taken care of many patients with metastatic cancer, I am hopeful that today's action will improve the lives of patients suffering from this disease." Currently, Revolution said it is "moving as quickly as possible to ensure safe and equitable access to daraxonrasib for eligible patients in the United States." The company also said it will provide the drug at no cost to patients in the expanded access program. Typically, insurance does not cover expanded access drugs before FDA approves them. (Rowland, Washington Post, 5/1)
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