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
Price :
$35
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At a glance
- Drugs Eflapegrastim (Primary) ; Cyclophosphamide; Docetaxel; Pegfilgrastim
- Indications Neutropenia
- Focus Registrational; Therapeutic Use
- Acronyms ADVANCE
- 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.
- 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.