Compassionate Use at Celldex Therapeutics
Celldex was founded on the scientific belief that unlocking the power of the immune system through the development and commercialization of targeted medicines has the potential to change the standard of care, including quality of life, for patients who suffer from life-threatening diseases.
Before our investigational medicines can be made broadly available, the U.S. Food and Drug Administration (FDA) and other worldwide health authorities require that they are studied in clinical trials to determine if they are safe and effective. At Celldex, our focus is on enrolling patients in clinical trials to obtain the data required for review and approval by these regulatory authorities. People who take part in clinical trials play important roles in the development of new treatments.
In some instances, patients with serious or life-threatening diseases may not be eligible for any clinical trials and may not have other treatment options. In very specific circumstances, Celldex may provide access to our investigational products to patients with life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk as defined in our Compassionate Use or Expanded Access Program.
In general, a treating physician, who has experience with the investigational product and is able to comply with the requirements that are stated in our Program, may apply for access to Celldex’s investigational products on behalf of their patient(s).