PATIENTS
PATIENTS
Expanded Access Policy
Arvinas is a biotechnology company focused on developing first-in-class protein degradation therapeutics for cancers and other difficult-to-treat diseases.
Expanded access, also called compassionate use, refers to a pathway in which patients with serious or immediately life-threatening diseases may be able to receive an investigational therapy outside of a clinical trial where all other viable treatment options (including participation in a clinical trial) have been exhausted.
Expanded Access Criteria
We review requests for patients with serious or life-threatening conditions based on the following criteria:
- There is sufficient evidence that the potential benefits to the patient outweigh the potential risks in the context of the disease or condition to be treated with the investigational drug.
- Providing the investigational drug will not interfere with clinical trials that could support the development or marketing approval for the treatment indication.
- The patient is ineligible for, or is unable to access a clinical trial, and lacks a suitable treatment alternative.
- The use of the investigational drug will be monitored and controlled appropriately and adequately by a licensed physician who is qualified to administer the investigational drug in a safe manner and who practices at a facility that has the capability, including adequate equipment and personnel, to provide any care for the patient needed in connection with the administration of such drug.
- The request, and Arvinas’ grant of the request, would be compliant with applicable local, state/provincial, and federal/national laws and regulations, as well as industry standards.
How to Submit a Request
Physicians can submit a request on behalf of their patient to medicalaffairs@arvinas.com. Requests must include the following information:
- The name, contact information and professional designation, e.g., MD, of the requesting physician,
- The name of the requested investigational drug, and
- A brief summary of the patient’s history to support use in the indication.
Please avoid sending personal health information about the patient with your request. We aim to respond to requests from physicians within 3 business days. If a patient submits a request to Arvinas directly, Arvinas will respond by asking the patient to have his or her physician submit the request.
Contact Information
- If you have any questions about our expanded access policy, please contact Arvinas through the following email address: medicalaffairs@arvinas.com.
- Information on all ongoing investigational trials sponsored by Arvinas can be found at clinicaltrials.gov by searching “Arvinas” in the “sponsor” field under the heading “Advanced Search.”
As authorized by the 21st Century Cures Act, Arvinas may revise this expanded access policy at any time. Additionally, the posting of this policy by Arvinas shall not serve as a guarantee of access to any specific investigational drug by any individual patient. Arvinas’ decision to grant or deny a request for expanded access may be modified or reversed by Arvinas at any time, and is subject to Arvinas’ continuing evaluation of safety and efficacy data of the investigational drug, as well as other considerations related to Arvinas’ sustainability, inventory, manufacturing, and clinical development programs.