First Patient Treated Under Right to Try Law
Patient diagnosed with an aggressive form of brain cancer became the first person in the US to access an experimental treatment under the Right to Try law of 2017.
Right-to-try laws are U.S. state and Federal laws that were created to let terminally ill patients try experimental therapies (drugs, biologics, devices) that have completed Phase I testing but have not been approved by the Food and Drug Administration (FDA).
According to BioCentury, FDA’s Oncology Center of Excellence is also working on a new initiative, known as Project Facilitate, under which the agency will provide a telephone number that patients and physicians seeking expanded access to an experimental treatment can call. FDA staff will answer calls and fill out the form required to apply for a single-patient IND request. The paperwork will be forwarded to the manufacturer. A pilot version of this initiative is expected to launch in the first half of 2019.