Oncology Times

Skip Navigation LinksHome > September 25, 2012 - Volume 34 - Issue 18 > FDA Approves Tbo-Filgrastim for Severe Neutropenia
Oncology Times:
doi: 10.1097/01.COT.0000421357.42399.e2

FDA Approves Tbo-Filgrastim for Severe Neutropenia

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The Food and Drug Administration has approved the use of tbo-filgrastim, made by Sicor Biotech, to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia. The drug is intended for use in adults who have non-myeloid malignancies and are taking chemotherapy drugs that cause a substantial decrease in the production of neutrophils in the bone marrow, which may lead to febrile neutropenia.

Tbo-filgrastim, which stimulates the bone marrow to increase the production of neutrophils, is administered as an injection beginning 24 hours after chemotherapy.

“Supportive care products, such as tbo-filgrastim, reduce or allow for more rapid recovery from side effects of cancer treatments,” Richard Pazdur, MD, Director of the FDA's Office of Hematology and Oncology Products, said in a statement.

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Tbo-filgrastim was evaluated in a clinical study of 348 adults with advanced breast cancer receiving doxorubicin and docetaxel. Patients were randomly assigned to receive tbo-filgrastim, a placebo, or a non-U.S.-approved filgrastim product. 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 for those receiving 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. The most common side effect observed in those receiving tbo-filgrastim was bone pain.

© 2012 Lippincott Williams & Wilkins, Inc.

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Pamela Tarapchak

ISSN: 0276-2234

Online ISSN: 1548-4688

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