Expanded Access Policy

Iovance Biotherapeutics, Inc. (Iovance) is committed to developing immuno-oncology TIL therapies for patients with serious cancers. Our goal is to provide access to our investigational therapies primarily through ongoing clinical trials.

“Expanded Access” refers to the use of an investigational therapy outside a clinical trial for potential treatment of a serious condition in a patient. The US Food and Drug Administration has set forth guidelines when considering expanded access. They include:

The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or enrolling clinical trials)

  • There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information
  • Whether granting expanded access would potentially compromise the scientific validity of broader development programs or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients.

Certain therapies, like TIL therapy, are made through complex manufacturing processes.  Iovance seeks to retain the ability to make and supply product in a fair and equitable manner and in a volume that assures adequate manufacturing capacity for ongoing clinical trials and development programs. Iovance believes that participation in one of its’ clinical trials is the most appropriate way to access these investigational therapies.

At this time, Iovance is not currently making its unapproved therapies available on an expanded access or right to try basis.  In the event Iovance decides to consider expanded access or right to try use, Iovance will evaluate and respond to each request that it receives on a case-by-case basis. You may reference information about our therapy and ongoing clinical trials by accessing http://www.iovance.com/clinical/our-clinical-program or https://clinicaltrials.gov.

 

If you have additional questions, please speak with your physician or contact the call center at 1-866-565-4410.

 

Consistent with the 21st Century Cures Act, Iovance may revise this policy at any time.