Expanded Access to our Investigational Medicinal Products Policy
At MorphoSys, our mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Before these and all other investigational medicinal products can be made broadly available, the U.S. Food and Drug Administration (FDA) and other health authorities around the world require that they are investigated in clinical trials. Throughout this process, the safety of patients taking our medicines is of the utmost importance.
Clinical trials are research investigations that are designed to determine if a medicine is safe and effective for patients.
People who choose to participate in clinical trials play an essential role in developing new medicines, particularly for rare diseases and conditions that are especially difficult to treat. Whenever possible, MorphoSys will refer an individual requesting access to our investigational medicinal products to an appropriate clinical trial.
For more information about MorphoSys’ ongoing clinical trials, visit tafasitamab on the website or ClinicalTrials.gov and search “MorphoSys”. To discuss your eligibility for a MorphoSys clinical trial, please ask your treating physician.
In some cases, patients with serious or immediately life-threatening diseases may not be eligible for any clinical trials and may not have other treatment options. Only under exceptional and very specific circumstances, these patients may be able to receive investigational medicinal products outside the clinical trial process.
These patients may be able to receive investigational medicines through “Expanded Access Programs” (EAP) (sometimes referred to as “Compassionate Use”).
EAPs can be set-up for patients:
- With serious or life-threatening diseases
- Who have exhausted all treatment options and
- Who are not eligible for any clinical trial
MorphoSys is committed to providing access to investigational medicinal products in cooperation with local health authorities and in accordance with our criteria for an EAP. EAPs only apply to investigational medicinal products not yet approved by the local health authorities.
How to Request Access to MorphoSys Investigational Medicinal Products
If you are a patient and interested in obtaining access to an investigational medicinal product, you should discuss available options with your treating physician. If a MorphoSys clinical trial may be a good treatment option for you, we recommend that your treating physician contacts us on your behalf via the contact information provided in ClinicalTrials.gov (search for tafasitamab).
If you are not eligible for a clinical trial that is currently active, or if no appropriate clinical trials exist, please contact your treating physician to determine if an EAP may be the best or only treatment option for you. Your physician will find details on the EAP at ClinicalTrials.gov with the identifier NCT04300803.
Treating physicians should use the following contact (email@example.com) to receive the necessary request form, eligibility criteria and instructions for the EAP process. Receipt of requests will be acknowledged within two business days of receipt, approval or denial will usually be finalized within 2-3 business days. Before treatment can be started, the treating physician has to obtain IRB review and FDA authorization.
MorphoSys is committed to a fair and impartial evaluation of each request for access to our EAP. Therefore, all decisions are based solely on clinical evidence and guided by the principles outlined below and by eligibility criteria for the EAP. In addition, MorphoSys intends to work in cooperation with local health authorities for the provision of an EAP.
MorphoSys May Consider Providing Participation in an EAP to a Patient if the following Principles Are Observed:
- Access to the MorphoSys investigational medicinal product is for a patient(s) with a serious or life-threatening condition for whom no other treatment options or clinical trials are available. If and when appropriate, an EAP is a solution of last resort if regulatory requirements allows.
- MorphoSys must be conducting research with the requested investigational medicinal product as part of a clinical trial. Upon commercial availability of the medicine, following local health authority approval, any applicable EAPs will be terminated.
- Granting participation in a MorphoSys EAP must not interfere in any way with the completion of clinical trials that could support health authority approval of the investigational medicinal product. Whenever possible, patients requesting access to a MorphoSys investigational medicinal product will be referred to an ongoing clinical trial.
- Patient must not be eligible for ongoing or pending clinical trials of the investigational medicinal product
- Potential benefits to the patient seeking access to the investigational medicinal product must outweigh the collective potential risks to the patient. The patient’s physician must decide whether the potential benefit outweighs the risk of receiving an investigational or unapproved medicine, based on the individual patient’s medical history.
- Adequate clinical data must exist to support the appropriate dosing, frequency of the investigational medicinal product and duration of treatment. MorphoSys’ clinical team will determine whether this clinical data is available and is adequate.
- Sufficient supply of the investigational medicinal product to support the EAP. Supplying the medicine through the EAP must not compromise the supply of medicine available for active or soon-opening clinical trials.