Xencor Expanded Access Policy
Xencor, Inc. is a biopharmaceutical company focused on discovering and developing novel, biological drugs. Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug. The following is Xencor’s policy for evaluating and responding to requests for individual patient access to investigational drugs that are intended to treat serious diseases.
Xencor believes that investigational drugs should be studied in patients as part of clinical trials designed to obtain data on safety and efficacy that may be used to support approval of the product and subsequent wider accessibility to patients. We encourage patients to speak with their physicians and to participate in clinical trials. In rare cases when patients with serious diseases are unable to participate in clinical trials and have exhausted all available therapies, Xencor may consider providing an investigational drug outside of a clinical trial. As a general policy, Xencor will not provide investigational drug until sufficient preliminary safety and efficacy information has been obtained in clinical trials, typically following Phase 2 investigation.
Xencor will evaluate and respond to a request that it receives on a case-by-case basis, applying the following criteria:
- There must be adequate supply of the investigational product to meet the needs of the expanded access program without impairing Xencor’s clinical trials
- There is a good understanding of the indication for which use is requested
- The potential benefit must be considered to outweigh the collective potential risks to the patient
- There must be sufficient clinical data to identify an appropriate dose
- The program must be compliant with local rules and laws
- The program should be discontinued as soon as feasible when the drug is approved for the relevant use
- The treating physician is willing to open a Treatment IND with the FDA
A treating physician may submit questions or requests regarding expanded access to the following: MedicalAffairs@xencor.com
Additional information may be obtained from the U.S. Food and Drug Administration at https://www.fda.gov/downloads/newsevents/publichealthfocus/expandedaccesscompassionateuse/ucm504494.pdf
Requests should be submitted by the treating licensed physician and should include sufficient supporting detail to enable Xencor to evaluate the expanded access request. Please include contact information so Xencor can follow-up with the physician directly (i.e., address, phone number, e-mail). Requests for expanded access need to be made by the physician responsible for treating the patient, and each request needs to relate to a single patient. Submit sufficient supporting detail to enable Xencor to evaluate the expanded access request. The requesting physician would be expected to submit an Investigator IND, if appropriate, after Xencor review of the provided information. Xencor could provide the investigational drug necessary to support single-person expanded access if such provision does not hinder Xencor’s on-going clinical trials.
Xencor will endeavor to acknowledge receipt of any expanded access questions or requests within 5-10 business days of receipt.
This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.
As authorized by the 21st Century Cures Act, Xencor may revise this expanded access policy at any time. Additionally, the posting of the policy by Xencor shall not serve as a guarantee of access to any specific investigational drug for any patient.