Policy on Expanded Access to Investigational Drugs
When all available treatment options have been exhausted, patients and their physicians may seek access to novel investigational medications and therapies before they have been approved or become available in their country. This is sometimes called “expanded access” or “compassionate use”; we will refer to this as “expanded access” in this policy.
Commitment to Expanded Access
Arcus Biosciences’ goal is to discover and develop novel combinations for the treatment of cancer that provide a substantial benefit to patients over currently available therapies. This is a challenging undertaking and one that will only be made possible through the participation of patients in our clinical trials. We believe it is primarily through these clinical trials and the generation of safety and efficacy data to support any application for regulatory approval that we can have the greatest impact on the patients whom our medicines are designed to benefit.
We recognize that patients with serious or life-threatening conditions may not qualify for clinical trials due to the specific criteria of a trial (e.g., progression of disease, previous medical treatment and concurrent medical conditions) and yet are in need of investigational therapies because no other alternative exists.
Criteria for Expanded Access
Arcus Biosciences is committed to reviewing each request for expanded access carefully and equitably. Our decision will be guided by the following criteria, each of which must be met before a patient can be considered a candidate for expanded access:
Process for Applying for Expanded Access
It is important to remember that investigational therapies have not yet been approved by regulatory agencies, and therefore their safety and efficacy have not been proven. Patients and their physicians need to carefully weigh the possible risks and benefits before beginning an investigational treatment.
Medical professionals at Arcus Biosciences will evaluate each request. We will endeavor to acknowledge each request within 5 business days and provide a decision within 30 days or less, assuming all required information has been provided to us to enable a decision.
To learn more about participating in clinical trials or ongoing Arcus Biosciences-led trials, please visit: