nab-sirolimus (ABI-009) Expanded Access Program
Aadi Bioscience, Inc (Aadi) is committed to helping patients with cancer obtain access to new treatments. While we believe this is best accomplished through participation in clinical trials, we recognize that this is not always possible for every cancer patient. In certain situations, Aadi may be able to provide pre approval access to nab-sirolimus through our Expanded Access Program.
To be eligible and considered for access to nab-sirolimus via Aadi’s Expanded Access Program, a physician must submit a request to Aadi
(Contact: Berta Grigorian firstname.lastname@example.org) and agree that the patient for whom the request is being submitted meets the following criteria:
1. The patient must have an immediately life-threatening condition or serious disease and:
- is not eligible to participate in any ongoing clinical study of nab-sirolimus
- has no comparable or satisfactory alternative therapies available to them
- the provision of the investigational agent will not interfere with the ongoing nab-sirolimus development program
2. The patients has received a diagnosis of either:
- Advanced (locally advanced and inoperable or metastatic) malignant PEComa confirmed by pathology and immunohistochemistry, whether or not previously exposed to an mTOR inhibitor
- Any other malignancy with activation in any mTOR pathway component as identified by immunohistochemistry or an identified relevant rare genetic mutation in mTOR pathway genes, including but not limited to TSC1, TSC2, PIK3CA, PTEN. Patients may or may-not have been previously exposed to a mTOR inhibitor
3. The potential benefits to the patient outweigh the potential risks
Approval of request will also be contingent upon whether Aadi has adequate supply of investigational product and whether there is a regulatory mechanism in the country or region to support expanded access. For additional information on our Expanded Access Program for nab-sirolimus and patient eligibility criteria please see: https://clinicaltrials.gov/ct2/show/NCT03817515
About Expanded Access:
In cases where a clinical trial isn’t an option, and the patient has exhausted all available treatment options, regulators/health authorities may grant permission for us to provide an investigational drug at the request of a licensed physician before it has been approved for commercial distribution. Such individual use of an investigational drug pre-approval is often called “expanded access” or “compassionate use”. For a patient to obtain access to an investigational drug candidate through expanded access, the patient’s physician, the drug’s sponsor and the regional regulatory authority must all approve the use.
It’s important to remember that investigational drugs have not yet received regulatory approval; therefore, their potential risks and benefits are not yet established. Doctors and patients should consider all possible benefits and risks when seeking expanded access to an investigational drug.