Expanded Access Programs & Policies

Expanded Access Programs & Policies

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.

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:

  • 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 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.