Access to investigational therapies

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:

• For an Exelixis investigational medication to be made available to a patient via early access, the patient must be diagnosed with a serious or immediately life-threatening disease for which no satisfactory treatment alternative exists.
• The medication must be under clinical development by Exelixis, and the provision of the medication must not compromise the clinical development program (e.g., the initiation, conduct or completion of trials) or the potential regulatory approval of the medication.
• Exelixis must have adequate supply of the medication.
• Sufficient data must exist to support its use in the specific clinical condition from which the patient suffers, and adequate data must also exist to identify an appropriate dose for use in such patients.
• Overall, the potential benefit to the patient must outweigh the potential risks to the patient.

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.