Rigorous clinical trials with our investigational therapies are designed to generate the comprehensive safety and efficacy data needed for the potential approval of new medicines and ultimately to expand available treatments for all patients.
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. Please note that only patients living outside of the U.S. are currently eligible for this program.
Review the criteria and process to request expanded access to a Day One investigational therapy.
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.
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 [email protected]. The following information must be included in any request:
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.
Our tovorafenib expanded access protocol (DAY101-EAP) has been registered at clinicaltrials.gov.
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