Drugs / Balugrastim
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | US (FDA) | — | neutropenia | — | “Last week, the company withdrew its balugrastim Biologics License Application (BLA) from the FDA review process” tevapharm.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01940601 | Sep 2014 → Nov 2015 | cancer | Teva Branded Pharmaceutical Products R&D, Inc. | Withdrawn | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00837265 | Aug 2008 → Jun 2009 | neutropenia | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2013-11-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Updates to Oncology Biologic Portfolio tevapharm.com ↗
Balugrastim Biologics License Application (BLA) withdrawn from FDA review process pending provision of additional confirmatory data |
| 2012-06-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Progress of Biologic Investigational Drugs Evaluated to Treat Neutropenia in Breast Cancer Patients Undergoing Chemotherapy tevapharm.com ↗
In both phase III breast cancer studies the primary endpoint was achieved, demonstrating reduction in the duration of severe neutropenia (DSN) in cycle 1, comparable to pegfilgrastim results in both efficacy and safety measures. |
| 2011-05-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Data on Granulocyte Colony Stimulating Factor Compounds for the Prevention of Chemotherapy-Induced Neutropenia in Breast Cancer Patients tevapharm.com ↗
A Phase II/III study of CG-10639, a long-acting recombinant human albumin-human G-CSF to prevent chemotherapy-induced neutropenia, demonstrated similar outcomes to pegfilgrastim (PEGF), for both efficacy and safety measures in breast cancer patients. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2013-11-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Updates to Oncology Biologic Portfolio tevapharm.com ↗ |
| 2012-06-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Progress of Biologic Investigational Drugs Evaluated to Treat Neutropenia in Breast Cancer Patients Undergoing Chemotherapy tevapharm.com ↗ |
| 2011-05-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Data on Granulocyte Colony Stimulating Factor Compounds for the Prevention of Chemotherapy-Induced Neutropenia in Breast Cancer Patients tevapharm.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Balugrastim | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00837265 ↗ |
| Known as | CG-10639 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108572 ↗ |
| Action | Activate | “Granulocyte colony stimulating factor receptor agonist” CHEMBL2108572 ↗ |
| Modality | Protein / enzyme biologic | “Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.” NCT00837265 ↗ |
| Route | Subcutaneous | “Participants will receive balugrastim low dose administered by subcutaneous (SC) injection once per chemotherapy cycle” NCT00837265 ↗ |
| Target | CSF3R | “Granulocyte colony stimulating factor receptor agonist” CHEMBL2108572 ↗ |