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.
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.