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Randomized, OpEn-Label, Active-ContrOl Trial of SPI-2012 (Eflapegrastim) Versus Pegfilgrastim in the Management of Chemotherapy-Induced Neutropenia in Early-Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER)

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Randomized, OpEn-Label, Active-ContrOl Trial of SPI-2012 (Eflapegrastim) Versus Pegfilgrastim in the Management of Chemotherapy-Induced Neutropenia in Early-Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER)

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 RECOVER
  • 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.
    • 17 Mar 2022 According to a Spectrum Pharmaceuticals media release, the company has resubmitted the Biologics License Application (BLA) with an expected six-month review for eflapegrastim following remediation of manufacturing deficiencies. The FDA has indicated that a reinspection of the drug substance manufacturing facility in South Korea will be required.

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