Aveta Biomics Expanded Access Policy
Aveta Biomics is committed to developing innovative treatments for cancer, including our investigational drug, APG-157, which has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for neoadjuvant treatment of head and neck cancer (HNC). While our priority is to bring APG-157 to market as efficiently as possible through clinical trials, we recognize that some patients with serious or life-threatening conditions may not qualify for clinical trials and may seek access to investigational treatments. In accordance with FDA guidelines and our ethical commitment to patients, Aveta Biomics has established an Expanded Access Policy.
What is Expanded Access?
Expanded Access, also known as “compassionate use,” is a potential pathway for patients with serious or life-threatening conditions to gain access to investigational therapies that are not yet approved by the FDA and not available through clinical trials. The FDA allows the use of an investigational drug outside of a clinical trial when all of the following conditions are met:
- The patient has a serious or life-threatening disease or condition.
- There are no comparable or satisfactory alternative therapies available.
- The patient is not eligible for clinical trials.
- The potential benefit of the investigational drug justifies the potential risks.
- Providing the drug will not interfere with clinical trials or the drug’s development program.
Criteria for Access
- The patient has been diagnosed with head and neck cancer (HNC) or another life-threatening cancer for which there are no satisfactory alternative treatment options.
- The patient is unable to participate in any of the ongoing clinical trials of APG-157.
- The patient’s treating physician determines that the potential benefit of receiving APG-157 outweighs the risks involved.
- There is sufficient clinical data available to support the safe use of APG-157 in the patient’s condition.
- The request complies with all applicable local and federal regulations, including obtaining the necessary regulatory approvals.
Process for Requesting Expanded Access
Treating physicians who wish to request expanded access to APG-157 for their patients must submit a request on behalf of the patient. To initiate this process, the following steps are required:
- Physician Request: The treating physician should contact Aveta Biomics at betterhealth@avetabiomics.com with a written request, detailing the patient’s medical condition, treatment history, and justification for requesting access to APG-157.
- Review: Aveta Biomics will review the request in consultation with the patient’s treating physician to assess eligibility based on the criteria outlined above. This review will be completed as quickly as possible.
- Regulatory Approval: If the request is approved, the treating physician will be required to obtain the necessary regulatory approvals, including submitting an Individual Patient Expanded Access IND (Investigational New Drug Application) to the FDA.
- Informed Consent: The treating physician must obtain the patient’s informed consent before administering the investigational drug.
Cost and Insurance
Aveta Biomics will not charge patients or their insurers for the investigational drug provided under expanded access. However, patients or physician or the payer may be responsible for the costs associated with the administration of the drug, medical care, and monitoring required as part of treatment.
Availability
Expanded access is contingent on the availability of sufficient drug supply and will be provided at Aveta Biomics’ discretion. APG-157 is currently under clinical investigation, and our priority is to ensure an adequate supply for ongoing clinical trials, which are essential to evaluating the drug’s safety and efficacy.
Limitations
While we aim to provide expanded access in accordance with FDA guidelines, not all requests can be accommodated. Expanded access requests may be declined for reasons including, but not limited to:
- Insufficient scientific/clinical evidence to support the safe use of APG-157 in the patient’s condition.
- Insufficient supply of the investigational drug.
- The potential to jeopardize ongoing clinical trials or the overall drug development program.
Contact Information
For further information regarding Aveta Biomics’ expanded access policy or to submit a request, please contact betterhealth@avetabiomics.com