Day One has established an expanded access program to provide eligible patients access to an investigational therapy in circumstances where the individual may not be eligible to participate in a clinical trial or where there are no clinical trials available.
Review the criteria and process to request expanded access to a Day One investigational therapy.
Criteria for expanded access
Day One is committed to reviewing all requests for expanded access in line with criteria consistent with local, regional, and international regulatory authorities. The following criteria must be met by the individual patient, the requesting healthcare provider (HCP) and the Day One investigational therapy in order for a request to be considered.
Criteria for patients
- The patient has a serious, debilitating or life-threatening medical condition with no suitable treatment available, and has exhausted current standard of care.
- In order for Day One to grant expanded access to an investigational therapy, there must be no comparable or satisfactory alternative therapy for the disease or condition, and the patient must have exhausted all available therapies typically used to treat the disease, and no longer be responsive to or able to tolerate these treatments. In addition, the patient must not be able to qualify for participation in, or have access to, any ongoing or pending Day One-sponsored clinical trial.
- Sufficient scientific and clinical data are available for both the disease condition and investigational therapy to indicate that the potential benefits of access to the investigational therapy outweigh any known potential risks as determined by the requesting healthcare provider.
Criteria for healthcare providers
- The healthcare provider must be currently licensed and routinely treat patients with cancer.
- The healthcare provider must report side effects of the investigational therapy to Day One.
- The healthcare provider must obtain approval for use from local regulatory authorities and ethics board, as applicable.
- The healthcare provider must obtain informed consent from the patient or his/her legal guardian(s) for treatment use of the investigational therapy.
- The healthcare provider must supervise administration of the investigational therapy in line with Day One defined access criteria (which in some countries may include a protocol for treatment use).
Criteria for the investigational agent
- There must be sufficient clinical data to identify an appropriate dose and an appropriate formulation.
- There is adequate supply of the investigational therapy to support an expanded access program, and such supply will not negatively impact a clinical trial or product anticipated for product launch or other required purposes.
- Expanded access does not impede or compromise the ongoing clinical development program or regulatory approval of the investigational therapy.
How to make a request for expanded access
Requests for access to a Day One investigational therapy must be made by the patient’s treating physician. Requests cannot be made directly by an individual patient or a patient’s parent/legal guardian or caregiver.
To make a request for expanded access, physicians should send an email to firstname.lastname@example.org. The following information must be included in any request:
- Requesting physician’s name, contact information, address (including country), and professional qualifications;
- Name of the requested Day One investigational therapy, the therapeutic indication and intended treatment plan;
- Medical rationale for the request, including an explanation why alternative therapies cannot be used, why the patient does not qualify for an ongoing clinical trial, why the potential benefit from the use of the investigational product outweighs the potential risks, and why those risks are not unreasonable in the context of the disease or condition being treated.
Day One is committed to evaluating all requests for expanded access in a fair and equitable manner. We will acknowledge requests from licensed physicians as soon as possible, generally within five business days of receipt. A decision will be made and communicated as soon as possible thereafter. Day One cannot guarantee that all requests for access will be granted, even when eligibility criteria are met.
Any expanded access to investigational therapies must comply with the applicable country-specific laws and regulations, including importation requirements, approvals from applicable regulatory bodies, and by an review appropriate Institutional Review Board or Ethics Committee. Day One may require agreements and/or certifications executed by the treating physician and other information to be provided prior to final approval of any request.
Patients and caregivers seeking information about access to our investigational therapies, either through a clinical trial or through expanded access, should consult with their treating physician.
Day One may revise this policy at any time in line with the 21st Century Cures Act.