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RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (TC) (ADVANCE)

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Trial Profile

RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (TC) (ADVANCE)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Oct 2022

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At a glance

  • Drugs Eflapegrastim (Primary) ; Cyclophosphamide; Docetaxel; Pegfilgrastim
  • Indications Neutropenia
  • Focus Registrational; Therapeutic Use
  • Acronyms ADVANCE
  • Sponsors Spectrum Pharmaceuticals

Most Recent Events

  • 01 Sep 2022 According to a Spectrum Pharmaceuticals media release, the U.S. Food and Drug Administration has approved ROLVEDON.
  • 11 Apr 2022 According to a Spectrum Pharmaceuticals media release, the company announced that the resubmitted Biologics License Application (BLA) for eflapegrastim has been accepted for filing. The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) goal date of September 9, 2022. The BLA for eflapegrastim is supported by data from ADVANCE and RECOVER trials.
  • 06 Aug 2021 According to a Spectrum Pharmaceuticals media release, the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) citing deficiencies related to manufacturing and indicated that a reinspection will be necessary. The company is seeking further clarification from the FDA and plans to meet with the agency as soon as possible.

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