Expanded Access/Compassionate Use
NewLink Genetics is a clinical stage biopharmaceutical company focusing on discovering, developing and commercializing novel immuno-oncology treatments to improve the lives of patients with cancer. Our product candidates are designed to harness multiple components of the immune system to combat cancer. Our mission is to develop and provide safe, effective and innovative medicines in areas of significant unmet medical need.
We recognize that not all potential patients in the U.S. will be able to access experimental medicines through a clinical trial and therefore may provide early access prior to FDA approval and in compliance with relevant US federal and state regulations, for life threatening, chronic or seriously disabling conditions when patients have exhausted all other options. We understand the need for compassionate use programs (may also be called expanded access, early access, special access, or by other names depending on the country from which the access is being requested) and we recognize the importance of having an appropriate policy.
A number of factors consistent with the U.S. Food and Drug Administration and other regulatory agencies’ guidelines should be taken into account when considering compassionate use. While NewLink Genetics believes that participation in one of our clinical trials is the most appropriate way to access our investigational therapies, expanded access to experimental or unlicensed product may be considered if the following criteria are met:
The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or enrolling clinical trials)
• There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information. If approved, physicians must agree to participate in NewLink Genetics’ safety monitoring and reporting requirements and follow FDA safety reporting regulations
• Only medicines under active clinical development in the U.S. by NewLink Genetics will be considered for Expanded Access. There must be sufficient clinical trial data on efficacy and safety indicating a potential benefit greater than risks for the intended use and dose. We must also be able to provide a product in a fair and equitable manner so that there is adequate manufacturing capacity for ongoing development programs
• Granting expanded access must not compromise the scientific validity of broader development programs, or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients
Requests for expanded access/compassionate use must be received from the patient’s treating physician in the United States on behalf of the patient. NewLink Genetics cannot guarantee that expanded access/compassionate use will be available for every experimental medicine or for any particular patient. Requests can be made by contacting firstname.lastname@example.org. We anticipate acknowledging receipt of requests sent to this email within five business days.