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Genentech Policy on Access to Investigational Therapies

Genentech discovers, develops and produces pharmaceuticals for significant unmet medical needs using the scientific advances of biotechnology. Investigational products are not generally available until after issuance of a marketing license by the U.S. Food and Drug Administration (FDA). Genentech agrees with FDA guidelines that our investigational products should usually be made available in cases where there are no alternate therapies for immediately life-threatening illnesses.

However, the primary goal of Genentech's product development effort is to conduct the necessary clinical trials to obtain the medical data that facilitates prompt regulatory approval for the product's unrestricted use under the supervision of licensed physicians. Any activity that interferes with this goal is not in the best interest of the majority of patients suffering from the disease.

Therefore, under the following programs and conditions, Genentech will usually provide access to its investigational drugs that represent potentially significant medical advances for immediately life-threatening illnesses for which no alternate treatments are available. Access will only be provided under these programs, and there will be no individual patient exceptions allowed.

Parallel Track/Treatment Protocol (a.k.a. Expanded Access)

  1. Genentech will provide access to its investigational drug under a parallel track, or treatment protocol, at the completion of Phase II clinical trials, in which safety and potential efficacy have been shown.
  2. A parallel track, or treatment protocol, program will be dependent on drug availability beyond that needed to conduct pivotal trials. The size of this program may necessarily be small since there is generally very limited supply of product at this stage of development.
  3. Patients who are not eligible for enrollment into the controlled or pivotal clinical trials will be considered for participation in this trial. In the case of limited supply, priority will be given to the most severely affected patients based on objective medical criteria.

Treatment IND or Protocol

  1. Genentech will provide access to its investigational drug under a Treatment IND or protocol at the completion of the pivotal trial showing that the investigational drug is sufficiently safe and effective to warrant seeking regulatory approval. The Treatment IND or protocol will be in effect during the regulatory and approval process.
  2. The size and starting date of the treatment protocol will be dictated by drug availability and the establishment of mechanisms to enroll patients and collect data.
  3. Patients eligible for this protocol must meet the criteria established for enrollment in the pivotal trial.

These guidelines apply to investigational products that are controlled solely by Genentech. In many cases, an investigational product is developed in cooperation with an alliance company or companies, and Genentech may not have sole control over access decision-making. In such cases, we will make every reasonable effort to ensure that these guidelines are followed.

For information about any of Genentech's products currently in development, call our Trial Information Support Line: 888-662-6728.