FDA Approves Tbo-filgrastim
FDA Approves Tbo-filgrastim for Severe Neutropenia in Certain Cancer Patients
August 29, 2012 -- The U.S. Food and Drug Administration today approved Sicor Biotech’s tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils.
Tbo-filgrastim is intended for use in adults who have cancers other than blood or bone marrow cancers (non-myeloid malignancies) and are taking chemotherapy drugs that cause a substantial decrease in the production of neutrophils in the bone marrow. This reduction in neutrophils may lead to infection and fever (febrile neutropenia).
Tbo-filgrastim stimulates the bone marrow to increase the production of neutrophils. It is administered as an injection beginning 24 hours after chemotherapy treatment.
“Supportive care products, such as tbo-filgrastim, reduce or allow for more rapid recovery from side effects of cancer treatments,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
Tbo-filgrastim was evaluated in a clinical study of 348 adult patients with advanced breast cancer receiving treatment with the anti-cancer drugs doxorubicin and docetaxel. Patients were randomly assigned to receive tbo-filgrastim, a placebo, or a non-U.S.-approved filgrastim product, a drug that also stimulates neutrophil production by the bone marrow. The effectiveness of tbo-filgrastim was determined based on study results that showed that patients receiving tbo-filgrastim recovered from severe neutropenia in 1.1 days compared with 3.8 days in those receiving the placebo.
Tbo-filgrastim’s safety was evaluated in three clinical studies composed of 680 adults with breast cancer, lung cancer, or non-Hodgkin’s lymphoma who received high-dose chemotherapy that reduces bone marrow cells (myeloablative chemotherapy). The most common side effect observed in those receiving tbo-filgrastim was bone pain.
Tbo-filgrastim is manufactured by Sicor Biotech UAB, a member of Teva Corporation.
Source: FDA
Posted: August 2012
Related articles
- Teva Announces Updated Indication and Vial Presentation for Granix (tbo-filgrastim) Injection in United States - August 6, 2018
- FDA Approves Teva’s Granix (tbo-filgrastim) Injection for Self-Administration - December 23, 2014
- Teva Announces FDA Accepts BLA for XM02 - February 2, 2010
- Teva Announces the Submission of a Biologics License Application (BLA) for XM02 for the Treatment of Chemotherapy-Induced Neutropenia - December 2, 2009
Granix (tbo-filgrastim) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of drugclasses.com in your inbox.