At Gritstone Oncology, we are committed to developing personalized immunotherapies to fight multiple cancer types. Our focus is on discovering and developing novel immunotherapies for patients who have the greatest clinical need.
Before Gritstone’s investigational medicines can be made broadly available, the U.S. Food and Drug Administration (FDA) and other health authorities around the world require that they are studied in clinical trials to determine if the medicines are safe and effective for prescription by physicians to patients, and that the benefits of their use outweigh the risks. Since Gritstone’s investigational medicinal products have not yet received regulatory approval, their safety and efficacy, with potential risks and benefits are not yet established. Throughout this clinical development process, the safety of patients taking our medicines is of the utmost importance; therefore, Gritstone maintains that participating in clinical trials is the best way for patients to access medicines prior to approval.
In some circumstances when clinical trial participation is not possible, patients with serious diseases or conditions may seek special access to investigational medicines. This access to investigational medicines is often referred to as expanded access or compassionate use.
Several factors consistent with the US FDA and other regulatory agencies’ guidelines should be evaluated when considering this access. They include:
- The patient has a serious or life-threatening illness.
- There are no comparable or satisfactory alternative therapies available.
- The patient is ineligible for, or otherwise unable to, participate in a clinical trial.
- The investigational medicine is currently being studied in clinical trials.
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks for the proposed use, typically after positive Phase 1 data is available.
- Expanded access to the experimental drug will not interfere with the conduct of clinical trials or other aspects of development that could impact approval for prescription use by the general public.
- The experimental drug can be provided in a fair and equitable manner, so that there is adequate manufacturing capacity for ongoing programs.
At this time, since Gritstone is in early clinical development (called Phase 1) and risks and benefits have not yet been adequately assessed, we are unable to provide investigational drug for expanded access/compassionate use. Therefore, participation in one of our clinical trials is the available path to access our investigational therapies. Information on Gritstone’s clinical trials can be found on clinicaltrials.gov
. If you have additional questions about participation in Gritstone’s clinical trials, please speak with your physician or contact one of the participating clinical trial sites listed on clinicaltrials.gov.
Consistent with the 21st Century Cures Act
, the posting of policies by drug manufacturers shall not serve as a guarantee of access to any specific investigational therapy by any individual patient. Gritstone Oncology will update this policy and its website as more clinical information becomes available on its investigational medicines.