Certain therapies, like TIL therapy, are made through complex manufacturing processes. Iovance seeks 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.
In certain situations where a patient is unable to participate in a clinical trial, and faces a serious or life-threatening condition, we may offer access to an investigational therapy through an expanded access program (EAP) or a compassionate use (CU) program. One investigational therapy is available through an EAP for patients with advanced (unresectable or metastatic) melanoma. Our other investigational therapies are available through our clinical trials. Iovance is opening sites for the EAP where the physician has access to facilities and staff to administer cell therapies and monitor the patient. The physician at the site must determine whether the EAP is in the patient’s best interest by weighing the benefits and risks of taking part. In addition, the US Food and Drug Administration has set forth guidelines when considering an EAP. 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
After a physician at an EAP treatment center identifies and submits a potential patient for the EAP, Iovance will review each request on a case-by-case basis for expanded access in a timely and fair manner. However, please understand that submitting a request does not guarantee access will be granted. Whenever possible, patients will be referred to ongoing clinical trials as the primary way to access investigational therapy.
How to Request Access:
Currently, Iovance has an EAP open for patients with advanced (unresectable or metastatic) melanoma. If the protocol is open and you meet the eligibility criteria, you should work with your doctor for referral to an EAP treatment center. Information on participating centers and eligibility criteria is available and will be regularly updated at clinicaltrials.gov. Treating physicians may request information by contacting: email@example.com. We will evaluate each request individually and will acknowledge receipt of the request within five business days of receipt.
As authorized by the 21st Century Cures Act, Iovance may revise this EAP at any time. Additionally, the posting of this policy by Iovance shall not serve as a guarantee of access to any specific investigational drug by any individual patient.