“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 Office of Hematology and Oncology Products, said in a statement.
The pivotal trial of tbo-filgrastim involved 348 women with advanced breast cancer treated with docetaxel and doxorubicin. Patients were randomized to G-CSF, placebo, or another form of G-CSF not available in the U.S. Recovery from chemotherapy-induced neutropenia occurred in an average of 1.1 days with tbo-filgrastim versus 3.8 days in the placebo group.
Read more: FDA Approves Short Acting Neutropenia Drug
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