Expanded Access Policy (EAP)
Kronos Bio is dedicated to the development of novel cancer therapeutics designed to transform patient outcomes by targeting dysregulated transcription.
Our Expanded Access Policy (EAP) refers to the use of an investigational therapies outside of a clinical trial. Sometimes called “compassionate use,” expanded access is a potential pathway for a patient to gain access to investigational therapies in certain rare circumstances in which a person has no other available therapies or is not eligible to participate in a current Kronos Bio clinical trial. Prior to health authority approval, evidence to support the potential benefit versus the risk of an investigational product is limited. At Kronos Bio, we recognize and understand the need for an expanded access policy for individuals who have serious or immediately life-threatening disease and have limited available treatment options. At the same time, we have to balance this with our obligation to avoid exposing people to investigational therapies with limited clinical data outside of a well-controlled study. This is both to prioritize patient safety and to preserve the integrity of data to provide for scientific assessment of the risks versus the benefits by competent authorities.
To establish an EAP that balances these imperatives, we rely on several key factors consistent with the U.S. Food and Drug Administration (FDA) and other regulatory agencies’ guidelines. These include, but are not limited, to the following:
- The patient or patients to be treated have a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition;
- The potential patient benefit justifies the potential risks of using the treatment and those potential risks are not unreasonable in the context of the disease or condition to be treated; and
- Providing the investigational drug for the requested use will not interfere with the initiation, conduct or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use.
We believe that participation in one of our clinical trials is the best way to access our investigational therapies. We encourage patients to speak with their health care providers regarding participating in clinical trials. In general, Kronos Bio will not provide our investigational therapies until sufficient preliminary safety and efficacy information has been obtained in our clinical trials, typically in the period between the readout of Phase 3 studies and regulatory approval and under an expanded access protocol.
If you are a patient who is interested in accessing our investigational therapies, please speak with your health care provider. You may also learn more about ongoing clinical trials by going to www.clinicaltrials.gov and searching for Kronos Bio.