Exelixis

Single-Patient EA Policies/Criteria Exelixis believes that the best way for a patient to have access to an investigational medication is through a clinical trial. Clinical trials, which may be sponsored by Exelixis or by another institution such as an academic medical center or a governmental body, enable rigorous systematic evaluation of a medication and allow for close monitoring of enrolled patients. Clinical trials, including eligibility criteria, are listed at ClinicalTrials.gov . Patients interested in learning if enrollment in a clinical trial is an option for them should consult with their treating physician. Patients who are not eligible for enrollment in a clinical trial may be able to access an investigational medication via early access. Early access is only available in limited circumstances for certain types of patients for which no other treatment options exist. Provision of an investigational medication by Exelixis will always be done in accordance with applicable laws and regulations. At Exelixis, early access to an investigational medication outside of a clinical trial might be possible through an “Expanded Access Program,” a single-patient investigational new drug application submitted to the U.S. Food and Drug Administration, or via a “Named Patient Use” program in other countries. The following are some of the general considerations for early access: Patients who are interested in obtaining early access to an Exelixis investigational medication should discuss the matter with their treating physician. A request for early access must come directly from the physician and should be conveyed to Exelixis Medical Information at medinfo@exelixis.com or by calling 1-855-292-3935. Physicians who administer Exelixis investigational medications through early access are required to comply with all applicable laws and regulations and contractual conditions, including those relating to safety reporting.