When patients with life-threatening cancer conditions have exhausted all other standard cancer treatments, enrollment in a clinical trial is an attractive option. However, a clinical trial may not be feasible for all patients for many reasons. For example, the institution offering the clinical trial may be too far, or a patient may not be eligible for clinical trial due to medical reasons. Under these circumstances, the patient and physician may consider trying unapproved/experimental but potentially beneficial treatments. Currently, access to these drugs is provided through “Expanded Access” or “compassionate use” programs.
In June 2019, the U.S. Food and Drug Administration Oncology Center of Excellence announced a new pilot program called “Project Facilitate”. This program is designed to assist health care professionals in requesting access to unapproved therapies for patients with cancer.
Physicians can submit a request for Expanded Access through this program.
During the application process, the FDA may weigh in on whether the potential benefit of the investigational treatment justifies the potential risks. Ultimately the pharmaceutical company that manufactures the experimental treatment will have to approve the request for experimental therapy.
Hopefully, this new initiative can assist physicians, patients, and their families in accessing experimental drugs when no other treatment options are available.
Reference: https://www.curetoday.com/conferences/asco-2019/fdas-project-facilitate-will-assist-requested-access-to-unapproved-cancer-therapies
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