Taking a novel approach to drug development

Compassionate Use Policy

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

According to the FDA’s published guidelines, compassionate use may be appropriate when all the following apply:

  1. Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition

  2. There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition

  3. The patient cannot get the medical product under another investigational medical product study or protocol

  4. The possible benefits to the patient justify the possible risks of the treatment, and those possible risks are not unreasonable given the disease or condition to be treated

  5. Providing the investigational medical product will not interfere with the clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access product

Lantern Pharma is committed to developing safe and effective therapies for patients and strives to put patients first.

Our goal is to provide best-in-class drug therapies to patients as soon as possible through efficient drug development and patient accessibility protocols.

Lantern Pharma does not currently have an expanded access program. However, we hope to offer one in the future, and information will be provided here if one is opened.

Contact Us About Compassionate Use

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