Juno’s Expanded Access Policy | Juno Therapeutics

Juno’s Expanded Access Policy

Juno Therapeutics is building a fully integrated biopharmaceutical company focused on developing innovative cellular immunotherapies for the treatment of cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine, Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. We conduct clinical trials to assess the safety and efficacy of investigational therapies, which if proven, will allow us to obtain the necessary approvals from regulatory authorities to provide patients with broad access to these treatments.

In general, Juno believes that participating in industry- or investigator-sponsored clinical trials that are designed to critically evaluate safety and efficacy is the best way for patients to access investigational therapies prior to approval. Please visit https://www.junotherapeutics.com/pipeline/clinical/ for additional information about Juno clinical programs. We are committed to developing safe and effective therapies for patients, and strive to put patients first. As part of that commitment, we believe that in certain cases, alternative means of access to investigational therapies is appropriate, and we therefore support expanded access and compassionate use programs.

To be considered for expanded access, the request must be submitted by a qualified and licensed physician with expertise and facilities appropriate for the administration of the investigational therapy, monitoring, managing and reporting side effects. Physicians should contact Juno by emailing medicalinformation@junotherapeutics.com with “Expanded Access Request” in the subject line. Juno will acknowledge receipt within 3 business days and will ask for additional information to evaluate the request. Juno will make a decision within 10 business days of receiving all required information.

Once Juno receives all required information, Juno will consider the following factors to determine if expanded access is appropriate for a particular patient. In all cases, the potential benefit to the patient must outweighs the risks. The following criteria will be used when making this assessment:

  • The clinical profile of the patient;
  • Whether an appropriate dose and/or treatment regimen for the investigational therapy has been determined;
  • A determination that the patient does not qualify for participation in clinical trials or are indicated to receive other approved therapies;
  • It has been established that access on an expanded use basis will not be detrimental to ongoing or pending clinical trials or the regulatory approval process;
  • There is manufacturing capacity for the investigational therapy;
  • All necessary regulatory/institutional approvals are obtained; and
  • Such other factors as deemed appropriate by Juno.

Juno cannot make a guarantee that the investigational therapy will be available to a particular patient. Any pre-approval access to investigational therapy must always comply with the applicable country-specific laws and regulations, including importation requirements, approvals from applicable regulatory bodies, and by an Institutional Review Board or Ethics Committee from the treating hospital.