Criteria for Consideration of Compassionate Use Access:

General Criteria

  1. The request must be submitted to Arog by the treating physician, with contact information so it can be followed up 
  2. There is a good understanding of the indication for the requested use.     
    1. There must be sufficient clinical data to identify an appropriate dose
  3. The potential benefit must be considered to outweigh the collective potential risks to the patient by offering the investigational product
    1. Patients with underlying conditions that may pose safety risks would not be eligible to participate
  4. Patient requirements:
    1. A serious or life-threatening disease or condition
    2. Exhausted all available therapies and is no longer responsive or able to tolerate these therapies
    3. No comparable or satisfactory alternative therapy is available to monitor or treat the disease or condition
  5. There must be adequate supply of the investigational product without impairing the Arog’s clinical trials
  6. In the United States, the FDA and IRB at the patient’s hospital must review and approve the use of the investigational product in the patient before Arog can provide it
  7. Anticipated Timing: Each request will be reviewed fairly and promptly by qualified Arog medical experts with every effort made to provide a response within a maximum of five working days once all required medical information has been received from the treating physician.

https://clinicaltrials.gov/ct2/show/NCT03620318?term=crenolanib&rank=14

Contact Information: Compassionate@arogpharma.com

Resources

https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/ucm20080392.htmperlink


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