Y-mAbs Therapeutics, Inc. (Y-mAbs) is a company built with a focus on patients with unmet medical needs in oncology. From time to time, we receive inquiries about making Y-mAbs’ investigational medicines available to patients with serious or life-threatening disease or condition for whom enrollment in clinical trials is not an option, and there are no beneficial therapies available.
In response, Y-mAbs has established the Expanded Access Program (EAP) as a way for certain patients to gain access to Y-mAbs investigational medicine on an “expanded access” or “compassionate use” basis if certain criteria are met.
Process
Currently, the EAP is available for 131I-omburtamab and naxitamab only in certain countries. For more information about, or to be considered for the EAP, a patient’s treating physician must first make a request via email to [email protected]. Once Y-mAbs has received all of the required information for consideration, an acknowledgement receipt of the request will typically be sent within five (5) business days. If you are a patient interested in Y-mAbs’ EAP, please talk to your doctor.
Evaluation Criteria
All EAP requests are carefully considered, and decisions are thoughtfully made based on various factors, with the patient’s safety and well-being at top of mind. However, Y-mAbs cannot guarantee that any specific request will be fulfilled and makes EAP decisions at its sole discretion.
Y-mAbs will evaluate each EAP request based on a variety of criteria and factors, which include but are not limited to the following:
Below are links to clinicaltrials.gov website where you can find Y-mAbs’ current clinical trials for naxitamab and 131I-omburtamab:
Y-mAbs reserves the right to revise its EAP policy in whole or in part at any time, without notice.