Trial Profile
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
Price :
$35
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At a glance
- Drugs Eflapegrastim (Primary) ; Cyclophosphamide; Docetaxel; Pegfilgrastim
- Indications Neutropenia
- Focus Registrational; Therapeutic Use
- Acronyms RECOVER
- Sponsors Spectrum Pharmaceuticals
- 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.