Expanded Access Program

In some cases, patients with a serious or life-threatening disease or medical condition may not be able to access one of our investigational medicines through a clinical trial and may not have other treatment options available. In very specific circumstances, these patients may be able to receive investigational medicines outside a controlled clinical trial through compassionate use programs (also sometimes referred to as “pre-approval access,” “expanded access,” “early access,” “named patient programs,” or “special access”). In all cases, providing an investigational medicine through these programs must be done in compliance with the regulations of the appropriate local health authority. Requests are reviewed based on scientific and clinical evidence and several important medical criteria including:

• The disease is serious or life-threatening;
• All other available alternative therapies have been exhausted, but the patient may still benefit from further treatment with a BeOne investigational product;
• A clinical study is not available, either because patients are ineligible or because they have no access to the trial;
• The efficacy and safety data available at the time are of sufficient strength to determine whether the benefit to the patient would likely outweigh the potential risks; and
• Access is compliant with all applicable laws and regulations.

If you are not eligible for a clinical trial or no appropriate clinical trial exists, and your qualified treating physician believes that an investigational medicine available through our Compassionate Use Program may be the best and the only treatment option for you, your physician should contact us on your behalf by emailing compassionateuse@beonemed.com. We strive to respond to compassionate use requests as quickly as possible; requests will be acknowledged within two business days of receipt.