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An Expanded Access Program of Surufatinib for Patients With Advanced or Metastatic Neuroendocrine Tumors

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Trial Profile

An Expanded Access Program of Surufatinib for Patients With Advanced or Metastatic Neuroendocrine Tumors

Status: Active, no longer recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 20 Jun 2023

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At a glance

  • Drugs Surufatinib (Primary)
  • Indications Neuroendocrine tumours; Pancreatic cancer
  • Focus Expanded access; Therapeutic Use
  • Sponsors Hutchison MediPharma; HUTCHMED

    • Most Recent Events

    • 02 May 2022 According to a HUTCHMED media release, U.S. Food and Drug Administration has issued a Complete Response Letter regarding the New Drug Application for surufatinib for the treatment of pancreatic and extra-pancreatic neuroendocrine tumors. FDA determined that the current data package, based on two positive Phase III trials in China and one bridging study in the United States (U.S.), does not support an approval in the U.S. at this time.
    • 02 May 2022 According to a HUTCHMED media release, the surufatinib Expanded Access Protocol (EAP) in the U.S. will no longer allow new patients to enroll in the study
    • 02 May 2022 According to a HUTCHMED media release, Status changed from recruiting to active, no longer recruiting.

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