Expanded Access
SurVaxM Expanded Access Policy
How MimiVax approaches requests for SurVaxM outside of a clinical trial — where things stand today, who may be eligible, and what we can and can’t provide.
Our commitment
Clear answers, even when they’re not the ones you hoped for.
MimiVax was founded to bring new treatment options to people living with glioblastoma and other cancers. Every request we receive for SurVaxM reminds us why that work matters, and we welcome patients, families and physicians to reach out.
This policy explains how we approach access to SurVaxM outside of clinical trials, where things stand today, and what you can do now. We have tried to write it plainly and honestly, because you deserve clear answers.
Where things stand today
SURVIVE has completed enrollment; our focus is finishing it.
SurVaxM is an investigational treatment that is not yet approved by the FDA. It has been studied in SURVIVE, a randomized Phase 2b trial in patients with newly diagnosed glioblastoma. SURVIVE has completed enrollment, and patients in the trial are continuing to be treated and followed.
Our focus now is on the steps that could lead to FDA approval: completing the SURVIVE study, meeting with the FDA, and preparing any confirmatory trial the agency might require. The SurVaxM we are able to manufacture today is reserved for SURVIVE and other ongoing trials, because they are the path to making SurVaxM available to everyone who might benefit. This means we cannot say yes to every request right now, and we do not take that lightly.
The FDA has granted SurVaxM Fast Track designation, and we are working with the agency to move as quickly as we responsibly can. We will update this page as soon as our ability to offer expanded access changes.
How expanded access will work
Who we expect to be eligible, once supply allows.
When the SurVaxM supply allows, MimiVax intends to offer SurVaxM through an expanded access program at selected accredited treatment centers, at no cost for the drug itself. The criteria below describe who we expect to be eligible. They reflect the patients in whom SurVaxM has been studied to date.
Who may be eligible
- Adults with newly diagnosed glioblastoma, age 65 or younger
- Patients who have had a gross total or near-total surgical resection
- Patients who have completed chemoradiation on the standard (Stupp) schedule and are able to receive adjuvant temozolomide
Expanded access will not include recurrent glioma or other types of brain or spinal cord tumors, or other cancers, because we do not yet have enough data to guide treatment in those settings.
How long treatment continues
When expanded access begins, patients may continue SurVaxM for up to 36 months, or until SurVaxM becomes commercially available, the treating oncologist feels it is no longer helping, side effects become unacceptable, or the tumor returns or progresses. The treating physician will remain in charge of care throughout.
Requests will be considered in the order received, and we will apply the same criteria to everyone.
What MimiVax can and cannot provide
We want families to be able to plan with clear expectations.
We will provide SurVaxM itself at no charge to patients enrolled in the program, and the support the treating center needs to administer it safely.
We are not able to provide travel to or from treatment centers, lodging, or reimbursement for any other expenses. As a small company, our resources must go toward manufacturing the drug and finishing the trials.
Please be aware that treatment centers may charge for related visits, blood tests, imaging or procedures, and that insurance coverage for these varies. We ask that every participating center discuss these costs with patients before treatment begins, so there are no surprises.
MimiVax may need to adjust or pause the program if drug supply changes. If that happens, patients already receiving SurVaxM will be our first priority, and we will communicate directly with their treating physicians.
What you can do now
Three places to start, whether or not expanded access fits today.
Ask about clinical trials
Although SURVIVE is no longer enrolling, MimiVax is planning confirmatory trials of SurVaxM, and we will post them on ClinicalTrials.gov and on this page as soon as they open. Other trials for newly diagnosed glioblastoma are also available at many centers, and your oncologist can help you find ones that fit your situation.
Talk with your care team
Your oncologist knows your situation best and can advise on all of the options open to you, including other clinical trials.
Stay in touch
If you would like to be notified when this policy changes, let us know using the form below. We will keep your information private and use it only for that purpose.
How to reach us
Physicians, patients and families are all welcome to write.
Questions about this policy or requests for expanded access should come from the treating physician, who can speak to a patient’s medical situation. Please use the form below — it routes directly to the team that reviews these requests, and asks for the acknowledgment required before we can respond.
We read and respond to every inquiry. If we are unable to provide SurVaxM, we will say so clearly and point you toward the options that are available.
Patients and families are welcome to write to us as well. We read every message, and we are honored that you would consider SurVaxM as part of your care.
This policy is posted in accordance with Section 561A of the Federal Food, Drug, and Cosmetic Act. Posting this policy does not guarantee access to SurVaxM. MimiVax may revise this policy at any time.