C4 Therapeutics, Inc., is committed to bringing new, innovative therapies to patients by continuously researching novel ways to treat cancer and other diseases through targeted protein degradation, conducting rigorous clinical trials and obtaining marketing approval by the U.S. Food and Drug Administration (FDA) and other regulatory authorities. As we advance our investigational therapies through clinical development, our goal is to provide access to these therapies at the appropriate time and in the manner that is in the best interest of the patients.
An expanded access program (EAP) , sometimes called compassionate use, is a potential pathway for a patient with a life-threatening condition or serious disease to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
On our website, both physicians and patients may explore information about our investigational agents. Our EAP policy is described below.
Several factors, consistent with guidelines published by the FDA and other regulatory agencies, are essential when considering expanded access requests, namely:
- The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or open clinical trials).
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information.
- The ability to provide a therapy in a fair and equitable manner so that there is adequate manufacturing capacity to provide therapies across all ongoing clinical trials and expanded access programs.
- Whether granting expanded access would potentially compromise the scientific validity of broader development programs or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients.
Given the early stage of our development programs, we believe that participation in our clinical trials, which are carefully designed to determine the safety and efficacy of our investigational therapy, is the most appropriate way to access our investigational therapies until sufficient evidence is available that suggests the potential benefit outweighs the risk. Therefore, we are not currently making our investigational products available through an expanded access program. If you have additional questions, please speak with your physician or have your physician contact clinicaltrials@c4therapeutics.com. We anticipate acknowledging receipt of requests sent to this email within five business days.
In line with the 21st Century Cures Act, C4 Therapeutics, Inc., may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov if such program becomes active.
