Frequently Asked Questions
At Genentech, our focus is on enrolling patients in clinical trials to obtain the data required for review and approval by regulatory authorities, including the U.S. Food and Drug Administration (FDA). In rare circumstances, we may provide patients with access to unapproved or investigational medicines outside the clinical trials process.
How can patients access an unapproved or investigational medicine
it is approved by the FDA?
Once the FDA approves a medicine, qualified healthcare professionals may give it to patients by prescription. Before a medicine is approved, it is considered an "investigational" or "unapproved medicine." Patients can only access investigational or unapproved medicines through one of three ways: clinical trials, expanded access programs (EAPs) or compassionate use (CU).
- How do I find a relevant clinical trial?
To find a clinical trial, visit clinicaltrials.gov.
For more information on Genentech Trials, call the Trial Information Support Line at 1 (888) 662-6728.
- What is an expanded access program?
Expanded access programs (EAPs) allow a limited group of patients to gain access to a specific investigational medicine before it is approved. These programs are designed to follow a specific clinical protocol. Companies who develop expanded access programs must do so in consultation with the Food and Drug Administration (FDA).
- What is compassionate use?
Compassionate Use (CU) is a way to provide an investigational medicine to an individual patient on humanitarian grounds when:
- the patient as a serious or immediately life-threatening condition;
- and does not qualify for any ongoing clinical trials (including an EAP);
- and has no other existing treatment options available.
While this approach may be available to a patient who does not have a specific disease or condition that is being investigated in clinical trials, there must always be sufficient data available to believe that the medicine will do more good than harm.
What is the Food and Drug Administration?
In the United States, The Food and Drug Administration (FDA) is responsible for approving the effectiveness and safety of medicines in the United States. In this capacity, the FDA oversees all aspects of how pharmaceutical and biotechnology companies develop, test, manufacture and commercialize medicines. Learn more about the FDA.
Who should I call for more information?
For Clinical Trials, call Genentech's Trial Information Support Line at 888-662-6728 (6 a.m. - 3 p.m. PST Monday to Friday). Please be prepared to provide relevant details, including but not limited to:
- Your relationship to the patient seeking treatment: Patient, relative, friend or treating doctor.
- The specific medical condition for which you are inquiring.
- Additional questions will be asked depending on this disease.
- The general medical status of the patient for whom treatment is being sought. Additional questions may be asked to further clarify eligibility.
- Where the patient for whom treatment is being sought lives.
For Compassionate Use, call Genentech's Compassionate Use Information Line: (844) 287-3783 (CU-REQUEST) 6 a.m. - 3.p.m. PST, Monday to Friday.