Expanded Access Policy
Investigational Medicines Currently Available Under Expanded Access
Pyxis Oncology does not currently offer an expanded access program. Access to our investigational medicines before dose and dosing regimens have been optimized, and safety and tolerability have been confirmed, may not be in the best interest of patients.
In accordance with the 21st Century Cures Act, below is our process for requesting access to investigational medicine. Please check this page periodically for updates to this policy and the potential availability of investigational medicines outside a clinical trial.
About Investigational Medicines
The most efficient and ethical manner for a patient to access an investigational medicine prior to it being approved by regulatory authorities is to enroll in a clinical trial. Well-designed and conducted clinical trials are essential in bringing new treatments to patients. People who choose to participate in clinical trials play a critical role in developing new medicines, the ultimate goal of which is to secure regulatory approval for the investigational medicine to be made available to as many patients as possible.
The sponsor of a clinical trial has an ethical responsibility to protect the rights and safety of clinical trial participants and ensure the integrity of the trials conducted. Individuals participating in Pyxis Oncology’s clinical trials are provided with the treatment being tested. These trials aim to discover whether the treatment is safe and efficacious. Until the regulatory authority has decided on the safety and efficacy, the treatment remains experimental and is not generally available to patients. However, patients who are not part of these trials and meet certain criteria (see below) can request access to the investigational medicine through their physician.
For a list of clinical trials currently recruiting patients, please visit https://clinicaltrials.gov/ and search for Pyxis Oncology.
Expanded Access Programs
Pyxis Oncology recognizes that in certain circumstances, enrollment to a controlled clinical trial may not always be possible for patients facing a serious or immediately life-threatening disease or condition, and access to investigational medicines may be sought outside of a clinical trial. These situations are typically referred to as expanded access programs (EAP) and are also called compassionate use or early access.
If you are not eligible for an open clinical trial, or if no appropriate clinical trials exist, and if your treating physician believes that an EAP may be the best or only treatment option for you, please ask him or her to contact Pyxis Oncology on your behalf at clinicaltrials@pyxisoncology.com.
For more information on expanded access and investigational medicines being offered, visit the Reagan-Udall Foundation for the FDA: https://navigator.reaganudall.org/.
How Requests are Evaluated
When a request is received for expanded access by a treating physician, Pyxis Oncology will acknowledge the request within five business days, will request information on the patient’s clinical history and proposed treatment plan, and will evaluate all requests based solely on clinical evidence and guided by the following principles:
- The patient’s disease progression and condition are considered life-threatening.
- The patient has exhausted or is ineligible for all other reasonable and available therapeutic options.
- All attempts to identify and qualify for a clinical trial have been unsuccessful.
- An adequate set of safety and efficacy data, including an established dose, is available (usually after completion of Phase 2 studies or receiving FDA Fast Track Designation).
- Granting access would not jeopardize ongoing clinical trials required for approval or cause a shortage of drug product needed for enrolled patients to complete a trial.
- A request for access was unsolicited by Pyxis Oncology or any other organization and received in writing from a treating physician.
- Potential benefits to the patient seeking access to the investigational medicine must outweigh the collective potential risks to the patient.
- The requesting treating physician confirms/agrees that they are properly licensed/qualified, will comply with applicable regulatory and safety reporting requirements, and have the facilities to receive and store investigational medicines under the required conditions.
How Decisions are Made
Pyxis Oncology is committed to a fair and impartial evaluation of each request for access to our investigational medicines. Access to investigational medicines is subject to local regulatory and ethical reviews/approvals, patient consent, and treating physician agreement with any safety monitoring that may be necessary.
Decisions will be based on the above criteria to ensure a fair review of EAP requests. Requests will be considered on a first-come-first-served basis for all patients dependent on investigational medicine availability.
Pyxis Oncology cannot make a guarantee that an EAP will be available, and even if an EAP is offered, Pyxis Oncology cannot make a guarantee that the investigational medicine will be available to a particular patient.
All decisions are based on each individual patient’s clinical circumstances. Outcomes of expanded access evaluations will be communicated to the treating physician in writing.
Pyxis Oncology will periodically review the expanded access program policy and reserves the right to modify the policy or change or discontinue the program at any time.
Last Updated 2025-02-19
