X
API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
0
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
ROLVEDON™ (eflapegrastim-xnst) injection is a long-acting G-CSF which decreases the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.
Lead Product(s): Eflapegrastim
Therapeutic Area: Hematology Product Name: Rolvedon
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 31, 2023
Details:
ROLVEDON™ (eflapegrastim-xnst) injection is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation,is indicated to decrease the incidence of infection, as manifested by febrile neutropenia.
Lead Product(s): Eflapegrastim
Therapeutic Area: Hematology Product Name: Rolvedon
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2022
Details:
Rolontis," a treatment for neutropenia and "Oraxol," as a treatment for metastatic breast cancer are under priority review by FDA. Hanmi is about to announce the results of their BLA/NDA approval respectively.
Lead Product(s): Eflapegrastim
Therapeutic Area: Oncology Product Name: Rolontis
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Spectrum Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2021
Details:
Spectrum expects to use the net proceeds for general corporate purposes, including the continued development of its pipeline assets, sales and marketing activities, pre-launch activities associated with ROLONTIS and potential business development initiatives.
Lead Product(s): Eflapegrastim,Docetaxel,Cyclophosphamide
Therapeutic Area: Oncology Product Name: Rolontis
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Jefferies
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering July 29, 2020
Details:
These data in rats suggest that eflapegrastim administered at the time of chemotherapy, rather than waiting 24 hours, may be able to provide prophylaxis against chemotherapy induced neutropenia.
Lead Product(s): Eflapegrastim,Docetaxel,Cyclophosphamide
Therapeutic Area: Oncology Product Name: Rolontis
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2020
Details:
The trial will evaluate the duration of severe neutropenia when administered at three different time points on the same day following standard chemotherapy in patients with early stage breast cancer.
Lead Product(s): Eflapegrastim,Docetaxel,Cyclophosphamide
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 30, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
