Extended Access use is a mechanism to provide medicinal product to an individual patient on humanitarian grounds outside of a
specific Puma-sponsored clinical study. This approach may be available to patients who do not have the specific disease or condition
under clinical investigation by Puma and, therefore, cannot participate in any Puma clinical trials.
Puma will consider providing individual patients access to alisertib outside of a clinical trial when all of the following criteria are met:
Inquiries will be addressed within five business days.
- The patient to be treated has a serious or immediately life-threatening disease or condition, and there is no comparable or
satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- There must be a clear biological or clinical rationale to anticipate a potential clinical benefit to the patient seeking access.
- This potential benefit justifies the potential risks of treatment and those potential risks are not unreasonable in the context of
the disease or condition to be treated.
- Providing medicinal product for the requested use will not interfere with the initiation, conduct, or completion of important
clinical trials that could support FDA approval or otherwise compromise the potential development of the product.
- The patient's qualified treating doctor makes a formal request and is committed to, and supportive of, the requested treatment.
- Such access must be allowed under local country laws and regulations.
Questions in reference to alisertib extended access should be emailed to EAP@pumabiotechnology.com.
In the United States:
Outside the United States:
- Questions from healthcare providers in reference to NERLYNX® (neratinib) should be directed to "Puma Patient Lynx™" by
visiting https://nerlynxhcp.com/access-and-support/ or by calling 1-855-816-5421, Monday - Friday, 9 am - 8 pm ET.