At Immunomedics we are committed to providing patients in need access to clinical trials in order to obtain the data required for review and approval by regulatory authorities, including the U.S. Food and Drug Administration (FDA).
Under select circumstances, we may provide certain U.S.-based patients access to an investigational medicine (i.e., one that has not been approved by FDA) outside of the formal clinical trial process through “Expanded Access,” sometimes also referred to as “Compassionate Use.” An Expanded Access Program (EAP) is intended to allow patient access to an investigational medicine for a serious or immediately life-threatening disease or condition where no comparable or satisfactory alternative therapy exists and when the potential benefit of the medicine justifies the potential risks, which are deemed reasonable in the context of the disease or condition being treated.
Our support of EAPs allows us to provide investigational therapies for U.S.-based patients who cannot enroll in a clinical trial. Further, we view EAPs as an important pathway of allowing such patients access to investigational medicines prior to FDA approval.
Any request for access to Immunomedics’ investigational drug sacituzumab govitecan, including those under the Right-to-Try Act as described in the U.S. Federal Food, Drug & Cosmetic Act (FFDCA) section 561B “Investigational Drugs for Use by Eligible Patients,” must be sponsored by a duly licensed U.S. healthcare professional. The Biologic License Application (BLA) for this drug for the indication of metastatic triple negative breast cancer (mTNBC) in patients who have received at least two (2) prior therapies for metastatic disease is currently under review by FDA and has an open Investigational New Drug (IND) application.
A qualified healthcare professional may find more information on how to submit a request for Expanded Access of sacituzumab govitecan on behalf of a patient by visiting the Expanded Access Navigator. In addition, health care providers may consult directly with the FDA’s Project Facilitate Call Center. You can contact the Call Center at 240-402-0004 or OncProjectFacilitate@fda.hhs.gov.
For additional questions, please email ExpandedAccess@immunomedics.com, or call Immunomedics Medical Information at (888) 983-IMMU (4668).
Immunomedics follows FDA regulations and guidance that: (i) describe criteria that must be met to authorize Expanded Access, (ii) that list requirements for Expanded Access submissions, and (iii) that describe safeguards to protect patients and preserve the ability to develop meaningful data regarding the use of the investigational product.
Immunomedics’ medical experts will evaluate all Expanded Access requests for patients with mTNBC based on the medical assessment of the risks and benefits for use in that specific patient. If potential patient benefit justifies the potential risks of the use of the investigational product and those risks are reasonable in the context of mTNBC, Immunomedics will work with the patient’s individual healthcare provider to determine if it is appropriate to grant Expanded Access of the investigational product. Not all requests may be granted.
Immunomedics will strive to respond to requests for Compassionate Use of an investigational product within five (5) business days of receiving a complete request that includes all necessary documentation. If Immunomedics agrees to the Compassionate Use request, the requesting healthcare provider will need to submit appropriate documentation to support the use of the investigational product for a specific patient, sometimes referred to as an Individual patient expanded access IND. FDA will typically take an additional two (2) to three (3) business days to approve requests that require a new patient-specific IND application. Once FDA has approved the Compassionate Use request, Immunomedics will work to expedite shipment of the drug to the healthcare provider who initiated the request and will be administering the drug.
Immunomedics may consider closing an EAP for various reasons, including, but not limited to: