Compassionate 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 may consider providing individual patients access to neratinib outside of a clinical trial when all of the following criteria are met:
In the United States:
- 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;
- The patient's qualified treating doctor makes a formal request and is committed to, and supportive of, the requested treatment.
On July 17, 2017 neratinib was approved for the extended adjuvant treatment of HER2-positive early stage breast cancer. Questions from healthcare providers regarding patients who fall within that indication should be directed to “Puma Patient Lynx,” our patient support program, 1-855-816-5421, Monday to Friday, 8am-8pm EST. Questions from healthcare providers regarding all other patients should be directed to email@example.com.
Outside the United States:
Puma offers a Managed Access Program (MAP) for patients outside the United States who meet the program’s inclusion criteria and where permitted by applicable rules, procedures and regulatory authorities. Information requests from healthcare providers outside the United States should be directed to firstname.lastname@example.org.
We anticipate acknowledging receipt of all requests within two business days.
Puma Biotechnology, Inc.
10880 Wilshire Blvd., Suite 2150
Los Angeles, CA 90024