Atara is committed to transforming the lives of patients with cancer and autoimmune diseases through innovative T-cell immunotherapies. Consistent with our commitment to bring safe and effective therapies to patients, we are focused on enrolling and conducting the clinical trials necessary for regulatory approvals to make our products broadly accessible as quickly and safely as possible. Participation in one of our clinical trials is the best and preferred route to access our investigational products.
“Expanded Access” is a pathway to use unapproved treatments outside of clinical trials, usually for severe or life-threatening conditions. At this time, Atara does not have any active Expanded Access Protocols nor do we provide access to our investigational products on an Expanded Access basis, and participation in our trials is the only way to access our investigational therapies.
We encourage physicians and patients interested in our investigational therapies to learn more about our ongoing studies by visiting clinicaltrials.gov and searching for Atara Biotherapeutics. If you are a physician interested in learning more about our investigational cell therapies or participating in our clinical trials, please submit a request to ClinicalStudies@atarabio.com.
In the event Atara decides to consider making one or more of its investigational candidates available for patients through an Expanded Access program, general review criteria to be considered may include: patient has a serious or immediately life-threatening disease or condition, availability of alternative products, the potential patient benefit justifies the potential risk of the treatment use, adequate supply and the investigational product candidate must be part of an active clinical development program at Atara, plausible scientific rationale which suggests that the patient may benefit, and any potential interference with Atara’s ongoing clinical trials. All requests would be evaluated on a case-by-case basis in a fair and equitable manner.