Expanded Access Program

Policy For Evaluating And Responding To Requests For Expanded Access To Investigational Drugs

The US Food and Drug Administration (FDA) describes investigational drugs as those that have not been approved or cleared by FDA. Therefore, the FDA has not determined these products to be safe and effective. Furthermore, the investigational drug may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects.

FDA has established criteria for the provision of investigational drugs to patients outside of clinical trials (compassionate use/expanded access). In part, that guidance provides that expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

Expanded access may be appropriate when all the following apply:

  • Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
  • There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
  • Patient enrollment in a clinical trial is not possible.
  • Potential patient benefit justifies the potential risks of treatment.
  • Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

Spectrum Pharmaceuticals is currently accepting applications for EAP access only to poziotinib. Applications will be accepted from physicians licensed/caring for patients in the United States, Canada, the United Kingdom, the European Union (excepting Germany and Belgium), Israel, and Japan.

Requests for Expanded Access must be submitted by licensed physicians to EAP@sppirx.com. Sufficient patient detail must be provided (using Spectrum’s application form and associated documentation) to permit the evaluation of appropriateness. Spectrum will endeavor to respond to complete submissions within 5 business days.

Expanded Access Program Application Form

Spectrum Pharmaceuticals is dedicated to our mission of acquiring, developing and commercializing novel and targeted pharmaceuticals for unmet medical needs. Information regarding Spectrum’s pipeline and ongoing clinical trials can be accessed here or https://www.clinicaltrials.gov.