Submit a physician request
Email betterhealth@avetabiomics.com with the patient’s diagnosis, treatment history, clinical status and medical rationale.
EXPANDED ACCESS
A thoughtful pathway when clinical trials are not an option.
Aveta evaluates physician requests for access to APG-157 in limited circumstances for patients with serious or life-threatening cancer.
Aveta Biomics Expanded Access Policy
Clinical trials remain the primary pathway for access to APG-157 and are essential to establishing its safety and efficacy. We recognize, however, that some patients with serious or life-threatening cancer may be unable to participate in a clinical trial. In limited circumstances, Aveta may consider physician requests for expanded access in accordance with applicable laws and FDA requirements.
APG-157 is an investigational product and has not been approved by the FDA or any other regulatory authority. Its safety and efficacy have not been established.
What is expanded access?
Expanded access, sometimes called compassionate use, allows an eligible patient to receive an investigational therapy outside a clinical trial when no comparable or satisfactory treatment option is available.
Who may be considered
- Serious or life-threatening cancer
- No comparable or satisfactory treatment option
- Unable to participate in an APG-157 clinical trial
- Potential benefit justifies the potential risks
- Access would not compromise clinical trials or development
Criteria for APG-157
Requests may be considered for patients with head and neck cancer or, case by case, another life-threatening cancer when adequate clinical evidence supports potential use. The treating physician must determine that the potential benefit outweighs the risks, and sufficient drug supply and clinical support must be available.
FOR TREATING PHYSICIANS
How to request expanded access
Aveta acknowledges receipt
Aveta will acknowledge a complete request within five business days and begin medical, scientific and supply review.
Obtain required approvals
If Aveta agrees to provide APG-157, the treating physician is responsible for FDA authorization and applicable Institutional Review Board approval.
Consent and oversight
The treating physician must obtain informed consent, administer treatment, monitor the patient and complete required safety reporting.
Cost
Aveta will not charge for APG-157 supplied through expanded access. Shipping and handling costs may be charged. The patient, physician, institution or insurer may be responsible for administration, medical care and monitoring costs.
Availability
Access depends on adequate drug supply and Aveta’s ability to support treatment without affecting ongoing clinical trials or development.
Important limitations
Not every request can be accommodated. Insufficient evidence, limited supply, patient safety concerns or potential interference with development may result in a request being declined.
EXPANDED ACCESS CONTACT
Requests must be submitted by the patient’s treating physician.
Posting this policy does not guarantee that expanded access will be provided.