Morning Briefing
Summaries of health policy coverage from major news organizations
Through 'Expanded Access' Program, FDA Wants To Remove Hurdles For Doctors Seeking Experimental Cancer Drugs
The Washington Post: FDA To Make It Easier For Doctors To Get Unapproved Cancer Drugs For Patients
The Food and Drug Administration plans to provide “concierge service” to doctors seeking access to unapproved drugs for cancer patients who have no other treatment options, the agency announced Monday. The goal is to remove any “perceived hurdles” for physicians who want to use the agency’s “expanded access” program, said Richard Pazdur, director of the agency’s Oncology Center for Excellence. The pilot program will include Project Facilitate, a new call center run by the agency’s oncology staff to provide a single point of contact for doctors submitting requests to the program. (McGinley, 6/3)
The Associated Press: US Aims To Help More Cancer Patients Try Experimental Drugs
Sally Atwater's doctor spent two months on calls, messages and paperwork to get her an experimental drug he thinks can fight the lung cancer that has spread to her brain and spine. Nancy Goodman begged eight companies to let her young son try experimental medicines for a brain tumor that ultimately killed him, and "only three of the companies even gave me a reason why they declined," she said. (Marchione, 6/3)
In other news —
Stat: Amgen’s Drug — Targeting An ‘Undruggable’ Cancer Protein — Shrank Tumors In Half Of Patients
For years, scientists said creating a drug around the KRAS protein was impossible. On Monday, Amgen showed it had developed a medicine that shrank tumors in 50% of lung cancer patients. These lung cancer patients — just 10 of them because this is an early-stage clinical trial — all had tumors that tested positive for a particular mutation in KRAS, a cell-signaling protein. The 50% response rate to AMG 510 is an improvement over the 30% response rate first reported by Amgen last month. It also exceeds investor expectations. (Feuerstein, 6/3)
