Expanded Access Policy

Expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational drug for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. 

ABM Therapeutics is currently offering an expanded access to the investigational drug ABM-1310 to a limited number of patients in the U.S. who have participated in clinical trials of ABM-1310. To be granted this expanded access, additional criteria must be met:

• The patient to be treated must have no comparable or satisfactory alternative therapy is available to treat the disease or condition;
• Available information exists to believe the potential benefit of treatment outweighs the potential risk in the context of the disease or condition to be treated;
• ABM Therapeutics has an adequate supply of the investigational drug;
• and providing the investigational drug will not interfere with ongoing clinical trial(s) or with the overall development program of ABM-1310.

 

Patients may be required to meet other important medical criteria established by ABM Therapeutics.

Each request will be reviewed fairly and promptly by ABM Therapeutics with every effort made to provide a response within a maximum of five-ten working days once all required information has been received from the treating physician. This timeline may be changed by factors such as government health authority feedback and the responsible IRB review/approval.

If expanded access is granted, ABM Therapeutics will provide the investigational drug free of charge to patients through their treating physician.

The Expanded Access Program

This is the physician-sponsored, single-patient expanded access (EA) to ABM-1310. ABM-1310 is an investigational small molecule inhibitor for treating patients with BRAFv600 mutant malignancies. This program currently is only available through licensed physicians in the United States and is offered to those patients who previously participated in an ABM-1310 clinical trial in the U.S., to allow them to continue receiving ABM-1310 therapy. ABM Therapeutic is the ABM-1310 drug provider and may provide possible assistance to the physicians for their EA applications.

Physician applicants are responsible for submitting required documents and obtaining all required approvals prior to requesting ABM-1310 drug supply. ABM reserves the right to review, approve or reject EA applications based on case-by-case evaluation. The ABM-1310 drug supply is free of charge to treating physicians and patients after all approvals are granted. All patient care is the responsibility of the treating physician and the patient’s own healthcare coverages.

A request must be submitted by the treating physician to contact@abmtx.com.

ABM Therapeutics may revise this expanded access policy at any time, including termination of this EA program. Additionally, the posting of this policy does not serve as a guarantee of access to any specific investigational new drug by any individual patient and their physician. If you have any questions, please contact ABM Therapeutics at contact@abmtx.com.