Access to Investigational Medicines
Exelixis sometimes receives requests for access to investigational medications, i.e. medications that have not received regulatory approval for any indication. We generally refer to these as “early access” requests. It is important to understand that early access is only available in limited circumstances for certain types of patients for which no other treatment options exist. Additionally, provision of an investigational medication by Exelixis will always be done in accordance with applicable laws and regulations.
Exelixis believes that the best way for a patient to have access to an investigational medication is via 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 www.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. 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 United States FDA, 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 undergoing 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.
Process for Requesting 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 email@example.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.
Note: A request for access to an investigational medication that is received from a country in which Exelixis has partnered with another company to develop the medication will be referred to that company for consideration according to that company’s practice.