Expanded Access – Our Promise

Stemline is committed to improving the life of patients by developing innovative therapies for the treatment of cancer. To do this, we conduct clinical trials to assess the safety and effectiveness of investigational medicines, which, if established, will help us obtain approvals from regulatory authorities and make the medicines commercially available for our patients.

EARLY ACCESS PROGRAM (EAP) DEFINITION AND CONSIDERATIONS

In some cases, when it is not possible for an individual to participate in a clinical trial and all other available medical options have been exhausted, the patient’s physician may seek access to Stemline’s investigational medicine outside of a clinical trial and/or before it is commercially available via Early Access Programs (EAPs).

Stemline has adopted the term “EAP,” which encompasses investigational medicine access mechanisms in a number of different countries, such as:

  • Temporary Authorizations for Use (ATU) in France
  • Expanded Access Programs (EAP)
  • Right to Try in the United States of America
  • Compassionate Use programs (CUP) in Spain and Italy

Stemline will only consider providing investigational medicine to patients pursuant to an EAP under the following circumstances:

  1. The initiation of an EAP does not jeopardize Stemline’s efforts to advance the clinical research process and gain regulatory approval of the investigational medicine.
  2. The EAP is not in conflict with the applicable regulatory guidelines within a particular country.
  3. The safety and efficacy of the investigational medicine in the particular indication must be reasonably established, as determined by Stemline’s Medical Affairs team, prior to providing the investigational medicine.
  4. Stemline has adequate supply of the investigational medicine.

Stemline will evaluate each product individually to decide on the most appropriate early access mechanism and program type.

MAKING A REQUEST FOR ACCESS TO AN INVESTIGATIONAL MEDICINE VIA AN EAP

When initiating an EAP, Stemline’s objectives are to ensure patient safety, serve the patient community with compassion and dignity, and make decisions as ethically and fairly as possible. In addition to the criteria set forth above, requests must meet the following criteria:

Patient

  • The patient suffers from a serious, debilitating or life-threatening disease
  • There are no other suitable alternative treatment options available to the patient
  • The patient is not eligible for enrollment in other ongoing Stemline-sponsored studies for that particular investigational medicine or indication

Physician

  • The physician must be qualified for managing and reporting side effects of the investigational medicine
  • The physician must obtain informed consent from the patient for participating in the early access program and procure the investigational medicine
  • The physician must supervise administration of the investigational medicine in line with Stemline’s defined access criteria (which in some countries may include a protocol for treatment use).
  • The request is for an approved use of a product
  • The treating physician reasonably expects that the patient will benefit from the treatment without undue safety risks

Requests for access must be made by the treating physician by email at (EUmedinfo@stemline.com) and should include the following details:

  1. Date of the request;
  2. Physician’s name, contact information, address, country and professional qualifications;
  3. Name of the investigational medicine and therapeutic indication, including treatment plan; and
  4. Medical rationale for the request and reason for exclusion from an existing clinical study, if applicable.

All requests received will be carefully reviewed by Stemline. Stemline commits to respond to requests within five business days of receipt of the request and required medical documentation. A decision will be communicated as soon as possible thereafter. However, the posting of this policy does not guarantee access to Stemline investigational medicines, even when eligibility criteria are met.

Patients or caregivers seeking access to Stemline investigational medicines should contact their treating physician.

Stemline reserves the right to revise this Policy at any time.