How can I receive BriaCell treatments?
Patients with metastatic breast cancer should see their oncologist and decide if participating in a clinical trial as a subject could be the preferred next treatment. If you and your doctor decide that trying an experimental treatment is best, then contact one of our clinical sites and the investigators or their representatives click here
For more help finding and connecting with a clinical trial site, you can also go to our related website
For those patients who do not qualify for a clinical trial, but along with their oncologist, feel that investigational experimental therapies may still be a good option, expanded access can sometimes help.
At this time, we are unable to provide access to our investigational treatment through a “compassionate use” or “pre-approval access” program for everyone. We are committed to working diligently with the FDA to gather the safety and efficacy data necessary for approval so that our investigational agents may become available to the greatest number of patients as quickly as possible. Our goal is to complete our clinical development program rapidly, but with all the scientific and clinical data that the FDA requires.
Until then, if you wish to be considered for potential expanded access, please have your oncologist (US inquires only) contact us with the required information below.
- Complete FDA form 3926
- Complete FDA form 1572
Once we receive all the above information from you and your oncologist, we will determine if BriaCell can potentially provide the investigational agent. Thereafter Briacell will provide a letter of authorization for use with the FDA submission once IRB approval has been documented. Before BriaCell releases any investigational product, your oncologist must submit confirmation of FDA approval.
Oncologist can enter the needed information and forms here;
BriaCell EAP policy consists of the following:
Subject to internal review, if consistent with all relevant policy and guidance, BriaCell may choose to provide an individual patient with our investigational agent outside of a clinical trial through the expanded access program, including through the use of single patient investigational new drug (IND) applications. We will only do so if supply is adequate, and the EAP request does not adversely affect the ongoing clinical trials. Re-supply if possible, will required evidence of continued benefit and absence of harm by providing redacted repeat imaging, labs and clinic note. Additional consideration of the request includes an assessment of the probability of harm versus benefit. Other factors include access to supportive care and professional licensed oncologists and oncology care. All the other above required documents and conditions also apply. We cannot guarantee any specific timeline for the consideration of any application so patients are encouraged to pursue other options at all times while awaiting a determination.
We will continue to reassess our compassionate use policy as circumstances dictate. Please continue to check our website for additional information.