Expanded Access Programs & Policies

Expanded Access Programs & Policies

Expanded access for an Investigational Medicinal Drug

Expanded access is for a patient with a serious or life-threatening disease or condition to try an investigational medical product for treatment outside of clinical trials when there are no comparable or satisfactory therapies available.

Investigational medical products are investigational drugs that have not been approved by FDA or other regulatory authorities. In the situation where patients have no further medical options, Y-mAbs Therapeutics, Inc. (Y-mAbs) may consider requests from physicians to make an investigational drug available to their patients on an “expanded access” basis. As these requests are complex Y-mAbs has gathered relevant information for expanded access and established a policy to govern requests from physicians for expanded access of investigational products for individual patients.

Expanded Access Programs for 131I-omburtamab

Y-mAbs Therapeutics, Inc. (Y-mAbs) has currently established an expanded access program for 131I-omburtamab at Memorial Sloan Kettering Cancer Center in New York for patients with central nervous system (CNS)/leptomeningeal disease, known to be omburtamab reactive.

In this expanded access program Y-mAbs is providing un-labeled omburtamab, but the treating site is responsible for radio-labeling with iodine-131 according to local practice which needs to be pre-approved by Y-mAbs. Y-mAbs offers the expanded access program for restricted patient populations unable to receive 131I-omburtamab under an ongoing clinical trial.

Expanded Access Programs for naxitamab

Y-mAbs has established an Expanded Access Program for naxitamab in patients with neuroblastoma.

Y-mAbs offers the Expanded Access Program for restricted patient populations unable to receive naxitamab under an ongoing clinical trial.

Y-mAbs will grant access to the expanded access program to physicians who undergo naxitamab training or have previously administered naxitamab and have established support services to safely administer naxitamab. Pre-approval by Y-mAbs is required for physicians who have not previously administered naxitamab. Naxitamab training will be required under these circumstances and will include product administration, and early recognition and management of the adverse events. Full approval by Y-mAbs will be grated to the physician once the sitetraining is complete.

Physicians may request evaluation for participation in Y-mAbs’ expanded access program for naxitamab by writing to the following email address: [email protected]. A template for Y-mAbs expanded access program will be provided to the physician once request have been received and training, when applicable, is completed.

Y-mAbs policy

For a patient to be evaluated for eligibility for the Y-mAbs naxitamab Expanded Access Program, a treating physician, on behalf of a specific patient, must submit a request to Y-mAbs. Send the request by email to [email protected] Once Y-mAbs has received all the required information, an acknowledgement receipt of the request will typically be sent within five (5) business days. The request will then be reviewed by the Y-mAbs expanded access review responsible person/committee. Y-mAbs will evaluate a request based on a variety of factors, which include but are not limited to:

  • The potential benefits of the experimental product may outweigh any potential risks;
  • The supply needs of the investigational product for the development program;
  • The patient is either ineligible or cannot participate in one of Y-mAbs’ on-going clinical trials for the investigational product;
  • Providing access to an investigational product cannot not have influence on the development program for the product, hereunder the ability to complete patient enrollment and other aspects of the clinical trials necessary to support registration of the product;
  • Other factors which Y-mAbs may deem appropriate to consider from time to time, in its full discretion.

Y-mAbs cannot guarantee access to Y-mAbs’ investigational agent. Y-mAbs retains all rights to approve or decline all expanded access requests in its full discretion.

If the request is approved by Y-mAbs, the patient’s country’s local regulatory authority(ies) must authorize the expanded access use in accordance with local regulations before the investigational medicine will be shipped to the requesting physician.

For further information on the currently available expanded access programs or treatment opportunities in Y-mAbs’ clinical trials, please contact Y-mAbs at the following email address: [email protected].

Below are links to Y-mAbs’ current investigational products in Phase 2:

The Company reserves the right to revise these policy statements in whole or in part at any time, without notice.