Zentalis Pharmaceuticals, Inc. (“Zentalis”) is dedicated to the discovery and development of small molecule therapeutics targeting fundamental biological pathways of cancer. Currently, Zentalis’ clinical product candidates are in clinical development, not yet approved by health authorities, such as the U.S. FDA, and therefore are “investigational drugs.” This phase of development means that more clinical studies are required and that health authorities have not yet found these products to be safe and effective for their specific use.
It is the FDA’s position that, whenever possible, an investigational drug should be used as part of a clinical trial. Therefore, Zentalis clinical trial programs are the primary way to access our investigational drugs prior to regulatory approval and we encourage patients to speak with their doctors to determine potential benefits, risks and eligibility to participate in such a clinical trial.
Where enrollment in a clinical trial is not an option, patients with serious or life-threatening diseases or conditions who have exhausted all other treatment options may receive investigational drug through another option commonly known as “Expanded Access” or “Compassionate Use”.
Per the FDA, Expanded Access may be appropriate when the below criteria are met:
- Patient has a serious disease or condition, or whose life is immediately threatened.
- There is no similar or satisfactory alternative therapy to diagnose, monitor or treat the disease or condition.
- Enrollment in a clinical trial is not possible.
- Possible patient benefit justifies the possible risks of treatment with investigational drugs.
- Providing the investigational medical product will not affect the investigational trials.
Generally, Zentalis does not provide investigational drugs to patients until there is sufficient data on the safety and efficacy of our products to allow patients and physicians to assess the risks and benefits of using these investigational drugs outside of a clinical trial context. Therefore, after careful consideration, Zentalis is not currently offering Expanded Access to investigational drugs.
In the future, Expanded Access may be reassessed for each of Zentalis’ investigational drugs as these advance further in clinical trials and more data to support the safety and effectiveness become available.
Posting this policy by Zentalis does not guarantee access to any specific investigational drug for any individual patient.
You can find additional information about Zentalis’ ongoing clinical trials on our website and by accessing https://clinicaltrials.gov.
If you have additional questions, please speak with your treating physician or contact Zentalis at at email@example.com.