Expanded Access Program Policy
Lantheus is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease.
Lantheus is focused on conducting clinical trials required by regulatory authorities to thoroughly answer important scientific questions about the potential risks and benefits of our investigational products. A clinical trial is a research program conducted to comprehensively evaluate the safety and effectiveness of an investigational product to treat or diagnose a disease or condition. An investigational product is a product that has not been reviewed or approved by the regulatory authority responsible for determining safety and effectiveness in a particular country. In the United States, the regulatory authority is the Food and Drug Administration or FDA. The data from clinical trials is provided to a regulatory authority, such as the FDA, to obtain regulatory approval for the investigational product. After receiving regulatory approval, Lantheus can make the product commercially available and healthcare providers (HCPs) can prescribe the product for patients who are most likely to benefit from the product. We are privileged to collaborate with clinical investigators, clinical trial teams, and patients, who all participate in our clinical trials to develop new, safe, and effective therapies. We encourage all patients and HCPs to visit the Innovation page of our website (www.lantheus.com) to learn more about Lantheus’ ongoing clinical trials and enrollment. Further information surrounding our clinical trials can also be found by searching the name of the investigational medicine on ClinicalTrials.gov.
We recognize that there are patients who will not be eligible for our clinical trials and may not have options for alternative therapies. For these patients, expanded access, which may also be called compassionate use, is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational product when no comparable or satisfactory alternative therapy options are available. In these situations, regulators/health authorities, such as FDA, may grant permission for Lantheus to provide a treating physician with an investigational product for a patient. Lantheus refers to these requests as expanded access.
Expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational product. It’s important to remember that investigational products have not yet received regulatory approval; therefore, their potential risks and benefits are not yet established. Physicians and patients should consider all possible benefits and risks when seeking expanded access to an investigational product.
The general criteria used by Lantheus to evaluate requests for expanded access include:
- The request must be submitted by a qualified and licensed HCP with expertise and facilities appropriate for the administration of the investigational product.
- The institution must have all necessary licenses, permits, facilities and equipment, including when applicable, the licenses, permits, facilities and equipment necessary to work with radiolabeled therapeutic products, and the treating HCP must have a proven track record in treating patients with radioligand therapies in a clinical trial or routine clinical care setting when the investigational product is a radiolabeled product.
- The patient must be located in the United States.
- The patient must have a serious or immediately life-threatening illness.
- The patient must not be eligible for, or cannot access, any ongoing clinical trials, and there is no satisfactory or comparable alternative therapy.
- The patient must satisfy the eligibility criteria outlined in the therapeutic protocol established for the expanded access program.
- The potential benefit of the investigational product to the patient must outweigh the potential risk. This should be evaluated by the patient’s HCP and discussed in detail with the patient.
- There must be an adequate supply of the investigational product, as determined by Lantheus in its sole discretion, over and above what is required for ongoing and planned clinical trials and other patients on, or who may begin, active treatment.
- The location of the facility where the product will be administered must be covered by Lantheus’ supply chain network; for example, if the investigational product is a radiopharmaceutical product, the site must be located close enough to the product manufacturing site so that sufficient therapeutic activity of the investigational product will be ensured at the time of delivery and administration.
There are additional criteria that must be satisfied by the HCP submitting the expanded access request, including:
- The HCP must agree to comply with all applicable legal and regulatory requirements in relation to the request and any requirements in terms of medical criteria (e.g., clinical monitoring), safety reporting or other data provision which Lantheus may require.
- The HCP must obtain the appropriate regulatory and ethics committee approvals and informed patient consent.
Lantheus is committed to providing a fair and equitable evaluation of all Expanded Access requests we receive. We will review requests on a case-by-case basis. Lantheus may require more detailed information in connection with any specific expanded access program in order to fully evaluate a request. The fact that one of our investigational products may be available through an expanded access program does not guarantee that our investigational product will be available for any particular patient, and the fact that the investigational product may be made available to one patient does not guarantee it will be made available to future patients. We cannot guarantee that all requests for access will be granted, even when eligibility criteria are met.
HCPs seeking access to a Lantheus investigational product should submit their requests to EAP-Info@lantheus.com, providing all information requested by Lantheus for that expanded access program. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within five (5) business days after receipt.
This policy is posted pursuant to the 21st Century Cures Act. Lantheus may revise this policy at any time and may establish different expanded access policies for each investigational product under development. Lantheus may discontinue expanded access to an investigational product at any time, or access may be terminated at any time by the FDA or a patient’s HCP. For more information about expanded access in the U.S., please visit the FDA Expanded Access page.
Information on available Expanded Access Programs at Lantheus:
Expanded access is not yet an option for any of Lantheus’ investigational products.
An expanded access program for our investigational product 177Lu-PNT2002 for qualifying patients located in the United States who have been diagnosed with PSMA avid metastatic castration-resistant prostate cancer is expected to be opened in the fourth quarter of 2023.