Together We Thrive
We know the stem cell transplant journey involves more than just the patient. It involves family members, caregivers, researchers and advocates, too.
For more information on the resources available to patients and their families, please email us at firstname.lastname@example.org.
Expanded Access Policy
Magenta also supports expanded access to investigational products where there is substantial scientific evidence to support the safety and the efficacy of a product for an indication when it is logistically feasible and when permitted by applicable law.
Expanded access refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. This is different from a clinical trial, where more comprehensive safety and efficacy data are collected. The intent of an expanded access program is to provide patients with access to investigational medication for serious diseases or conditions where there is no comparable or satisfactory alternative therapy available. We understand the need for expanded access programs, and we recognize the importance of having an appropriate policy.
Magenta will consider a number of factors consistent with the US Food and Drug Administration (FDA) and other regulatory agencies’ guidelines when reviewing requests for expanded access, including:
- An independent request from a qualified and licensed treating physician submitted to email@example.com that contains the requestor’s contact information as well as a description of the drug product requested, the disease to be treated, a rationale for the request, and any other relevant scientific and clinical information
- The patient or patients to be treated have a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to treat the disease or condition including approved products or enrolling in a clinical trial
- The potential patient benefit justifies the potential risks of the treatment use, and those risks are not unreasonable in the context of the disease or condition to be treated
- Granting expanded access would not 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
The above criteria are among those that Magenta will consider in determining whether to offer expanded access for individual use. However, Magenta cannot make any guarantee that the investigational therapy will be available for a particular patient. All individual requests will be evaluated in a fair, unbiased manner, and we anticipate acknowledging receipt of requests sent to firstname.lastname@example.org within five (5) business days.
At this time, Magenta believes that participation in one of our clinical trials is the most appropriate way to access our investigational therapies. If you have additional questions, please speak with your physician or contact email@example.com.
Consistent with the 21st Century Cures Act, Magenta is publicly disclosing their policy on making investigational drugs available for expanded access and may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.