Expanded Access to nab-sirolimus
Expanded Access Program for Advanced Malignant PEComa
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 investigational access to nab-sirolimus through our Expanded Access Program.
Requests for expanded access will be evaluated on a case-by-case basis and 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.
To be eligible, a physician must submit a request to Aadi (Contact: email@example.com) and agree with Aadi that the patient for whom the request is being submitted meets the following criteria:
1. The patient has received a diagnosis of locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa) and:
- Patient is ≥18 years of age
- Diagnosis is confirmed by pathology and immunohistochemistry
- Has no comparable or satisfactory alternative therapies available to them
- Patient may be eligible whether or not previously exposed to an mTOR inhibitor
2. The potential benefits to the patient outweigh the potential risks
3. The provision of the investigational agent will not interfere with the ongoing development program
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 is commercially available. 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.