Genentech will consider providing individual patients access to an investigational medicine outside of a clinical trial only when all of the following criteria are met:
The investigational medicine must be part of an active clinical development program (Genentech must be currently studying the medicine in patients). Once the FDA approves a medicine, neither existing expanded access programs nor compassionate use are available.
Granting access to an investigational medicine must not interfere with the completion of important clinical trials that could support FDA approval of the medicine or otherwise compromise the potential development of the investigational medicine.
Additionally, patients must not be eligible (i.e. do not qualify) for ongoing (or soon opening) clinical trials of the investigational medicine. Geographic limitations to participation in a clinical trial would generally not meet this criterion.
The potential benefit to the patient seeking access to the investigational medicine must always be considered to outweigh the collective potential risks to the patient of offering the medicine, including the outcome of the disease itself.
Additionally, patients with underlying medical conditions that may pose safety risks that have not been sufficiently characterized/studied would not be eligible to participate.
As applicable, there is sufficient clinical data to identify an appropriate dose (amount and frequency of the medicine given).
The program is limited to groups of patients who generally have the same stage, extent and type of disease or medical condition that was evaluated in the key study/studies that will be submitted to the FDA in support of an application for approval of the medicine.
Genentech must consider the risk-benefit to be robust and persuasive and reasonably likely to be supported by the FDA.
Based on discussions with the FDA, Genentech must have reason to believe the FDA is likely to approve the medicine for use in this population of patients.
The patient has: