Immatics is committed to delivering the power of T cell therapies and to unlocking new avenues for patients in their fight against cancer.
In the United States, expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to obtain access to an investigational therapy for treatment when no options for comparable or satisfactory alternative therapies or clinical trials are available. In those cases, patients may be eligible for treatment with an investigational therapy through a regulatory pathway administered under the regulations of the US Food and Drug Administration (FDA) known as ‘Expanded Access Programs’ (EAPs). It is important to remember that these investigational drugs have not yet been approved by FDA and have not yet been proven safe and effective.
These programs help provide eligible patients with a treatment outside the clinical trial setting that they would otherwise not be able to receive. To get access to a therapy via an EAP, the physician treating the patient must assess whether the potential benefit outweighs the risk of receiving an investigational or unapproved therapy.
Immatics is currently considering requests for expanded access to its investigational therapies in certain limited cases. Requests for expanded access will only be considered when made by the treating physician and will only be considered if the following criteria are met:
- The patient has a serious or immediate life-threatening disease or condition with no other satisfactory treatment options (such as approved products)
- The patient is ineligible or otherwise unable to participate in a clinical trial
- Sufficient efficacy and safety data are available to indicate that the potential benefit to the patient justifies the potential risks and to identify an appropriate dose of the drug;
- The requested drug is part of an active and ongoing Immatics development program;
- There is available supply of the requested drug; and
- Providing the investigational medical product will not interfere or delay current investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
Please note that there is no guarantee of acceptance even if all of the above criteria are met and when reviewing expanded access requests, Immatics may also consider other factors that are not listed above. If you are a patient with questions concerning access to an investigational medicine — either through a clinical trial or EAP use – please discuss your situation with your treating physician. Treating physicians may make expanded access requests by contacting Immatics at EAP@immatics.com. Immatics will carefully evaluate these requests on an individual, case-by-case basis and will acknowledge receipt of the request via telephone call or email within five business days of receipt.
The following information must be included in any request:
- Date of request;
- Requesting physician’s name, contact information, address (including country) and professional qualifications;
- Name of the requested Immatics investigational medicine, the therapeutic indication and the intended treatment plan; and
- Medical rationale for the request, including an explanation why alternative therapies cannot be used and why the patient does not qualify for a clinical trial.
As authorized by the 21st Century Cures Act, Immatics may revise this expanded access policy at any time. Additionally, the posting of this policy by Immatics shall not serve as a guarantee of access to any specific investigational therapy by any individual patient.