ABM Therapeutics

Single-Patient EA Policies/Criteria This is the physician-sponsored, single-patient extend 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 (ABM) 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. Available Therapies via Single-Patient EA The ABM-1310 single-patient EA is specifically for patients in the U.S. who previously participated in an ABM-1310 trial and continued ABM-1310 treatment when the trial ended. This EA is only for patients with advanced BRAFv600 mutant solid tumors including primary brain tumors.