Expanded Access Policy
Cue Biopharma is committed to developing safe and effective therapies and providing them as quickly as possible to cancer patients who are most likely to benefit based on our current understanding of how our therapies work alone or together with other treatments. However, we recognize that there may be interest in accessing these experimental therapies prior to regulatory approval through compassionate use and other pre-approval access programs.
We believe that participation in a clinical trial is the best way for patients to access our therapies prior to regulatory approval. In this setting, patients receive physician oversight, close monitoring and appropriate follow-up to ensure safe use of these investigational therapies. Expanded Access, also known as Compassionate Use, refers to the use of an investigational product that has not yet been approved by the U.S. Food and Drug Administration (FDA) to treat, diagnose, or prevent a serious disease or condition. Providing an investigational product as part of an Expanded Access Program is a complex matter and is different from studying the investigational product as part of a clinical trial, where more comprehensive safety and efficacy data are collected. We understand the need for Expanded Access Programs under certain circumstances, and we recognize the importance of each clinical trial sponsor thoughtfully considering all the issues and having an appropriate policy in place for responding to requests for this kind of expanded access.
Accordingly, when considering whether to grant an expanded access request from a patient who is outside of a clinical trial, or a treating physician, Cue Biopharma requires the following criteria to be met, in compliance with FDA Expanded Access (Compassionate Use) Policies:
- The request must be made by a qualified and licensed physician who is willing to comply with all institutional, ethics and health authority requirements.
- The treating center must be staffed with the appropriate personnel and equipment for safe administration;
- The patient has been diagnosed with a cancer that is being evaluated in Cue Biopharma-sponsored clinical trial(s);
- There must be substantial scientific evidence that the benefit to the patient would likely outweigh the potential risks, based on all available safety and efficacy information;
- Any underlying condition such as heart disease or a second cancer must not pose safety risks that have not been sufficiently studied per the exclusion criteria of our clinical studies;
- All necessary regulatory and institutional approvals have been obtained to allow for administration of the investigational product, and the physician, institution and patient must agree to comply with the company’s safety and monitoring requirements; Providing the investigational drug will not interfere with or delay clinical trials that could support the experimental drug’s further development or marketing approval; and There is adequate supply of the experimental therapy to support expanded access in addition to any ongoing or planned clinical trials and the company is able to provide it in a fair and equitable manner and in a manner that is not unduly burdensome to Cue Biopharma for any other reason in Cue Biopharma’s sole discretion.
We always keep patient safety front and center in our research and development efforts. When the above criteria are not met, Cue Biopharma will be unable to offer our investigational products to patients who are not participating in one of our supported clinical studies. Our main priority is to obtain regulatory approval from FDA so that these therapies can be made available to the largest number of patients as quickly as possible. We encourage all eligible patients to speak to their physicians about the possibility of enrolling in a clinical trial in order to gain access to investigational agents and also to support the development of promising new therapies.
Treating physicians, patients and/or caregivers who are interested in learning more about one of our investigational therapies can find more information by visiting www.clinicaltrials.gov and searching for “Cue Biopharma.”
Expanded Access requests must be directed to ExpandedAccess@cuebio.com and come from a U.S. treating physician with the following information included:
- The requesting physician’s name, contact information, address, professional designation (i.e., MD) and qualifications;
- Relevant medical information for the patient, including type of cancer, cancer treatments received, relevant medical history and current clinical status; and
- A written commitment to follow institutional and regulatory requirements that apply at the location where the patient will be treated.
Cue Biopharma will aim to respond to a complete physician’s request within 30 days.
The company will be re-evaluating this policy periodically and it