Expanded access for an Investigational Medicines

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.

Process

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.

Evaluation Criteria

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:

• The patient has a serious or life-threatening disease and there are no beneficial treatment options available;
• The potential benefits of the investigational medicine likely outweighs any potential risks;
• There is an adequate supply of the investigational medicine;
• The patient is either ineligible or cannot participate in on-going clinical trials for the investigational medicine;
• Information to inform the treating physician on the safe and appropriate use of the investigational medicine can be provided.
• Providing access to an investigational medicine does not interfere with the ability to complete patient enrollment and other aspects of the clinical trials necessary to support registration of the investigational medicine; and
• Other factors which Y-mAbs deems appropriate to consider from time to time, in its full discretion.

Below are links to clinicaltrials.gov website where you can find Y-mAbs’ current clinical trial for naxitamab:

• Naxitamab – NCT03363373

Y-mAbs reserves the right to revise its expanded access / compassionate use policy in whole or in part at any time, without notice.