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:
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.
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.