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Single-Patient EA Policies/Criteria

Zhejiang DTRM Biopharma Co. Ltd. is an oncology-focused Biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. Our development resources are focused on conducting scientific research that evaluates the safety and effectiveness of new medicines for patients with cancer. Our clinical trial programs are the primary way to get access to one of Zhejiang DTRM Biopharma’s investigational medicines. These clinical trials provide the most effective way to assess how our investigational medicines may treat cancer and are used to support regulatory approval. Zhejiang DTRM Biopharma encourages patients to speak with their treating physicians about participating in a clinical trial, when possible. You can find additional information about Zhejiang DTRM Biopharma’s ongoing clinical trials by accessing https://clinicaltrials.gov.
Where enrollment into a clinical trial is not an option, and where all currently available treatment options have been exhausted, an investigational medicine may be provided prior to regulatory approval or commercial availability, under a provision referred to as “Expanded Access” (also commonly called “Compassionate Use”) by the U.S. Food and Drug Administration (“FDA”).
Expanded Access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational drug for treatment outside of a clinical trial when no comparable or satisfactory alternative therapy exists. Per FDA, Expanded Access may be appropriate when all of the following apply:
1. A patient has a serious disease or condition, or a patient’s life is immediately threatened by their disease or condition.
2. There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
3. Patient enrollment in a clinical trial is not possible.
4. Potential patient benefits justify the potential risks of treatment.
5. Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
As a general policy, Zhejiang DTRM Biopharma will not provide investigational medicines to patients until a dose and schedule has been well established for the agent, preliminary data exists that the agent has some evidence of activity in a particular indication, and the agent is found to be safe as a result of a risk-benefit evaluation.
Zhejiang DTRM Biopharma is not currently making any of its investigational medicines available on an Expanded Access basis prior to regulatory approval anywhere in the world. Zhejiang DTRM Biopharma may reconsider making one or more of its investigational medicines available through an Expanded Access Program in the future. As authorized by the 21st Century Cures Act, Zhejiang DTRM Biopharma may revise this Expanded Access Policy at any time.
If you have additional questions, please speak with your treating physician or contact Zhejiang DTRM Biopharma at dtrm-555fdctablets@dtrmbiopharma.com