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.
Y-mAbs has established a process whereby certain patients may gain access to Y-mAbs investigational medicine on an “expanded access” or “compassionate use” basis if certain exceptional criteria are met. This process is available only in certain countries and for limited periods.
For countries in Europe:
DANYELZA® (naxitamab-gqgk) 40mg/10mL Injection will be available to patients contingent on meeting the eligibility criteria in Europe through a Named Patient Program (NPP) subject to receiving local approval.
For more information about, or to be considered for the the DANYELZA® Named Patient Program, the patient’s treating physician must first make a request via email to [email protected]. Further guidance and instructions will then be provided upon receiving this request.
For countries outside Europe:
For more information about, or to be considered for expanded access / compassionate use, 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 or enquiring on behalf of a patient interested in Y-mAbs’ expanded access / compassionate use, please talk to your doctor.
All requests for compassionate use of investigational medicines 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 decisions at its sole discretion.
Y-mAbs will evaluate each 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 trial for naxitamab:
Y-mAbs reserves the right to revise its expanded access / compassionate use policy in whole or in part at any time, without notice.