The FDA approved tbo-filgrastim (Neutroval; Sicor Biotech UAB, a member of Teva Corporation) to reduce the duration of severe neutropenia in patients with cancer receiving chemotherapy.
Tbo-filgrastim is a short-acting recombinant human granulocyte colony-stimulating factor that is indicated for use in patients with cancer, except blood or bone marrow cancers, who are receiving chemotherapies that cause febrile neutropenia. Tbo-filgrastim is administered as a subcutaneous injection, 5 mcg/kg, 24 hours after chemotherapy treatment.
The manufacturer submitted a Biologics License Application for this agent, which in the European Union is licensed as a biosimilar (ie, Tevagrastim) to Neupogen (filgrastim).
The FDA approval of tbo-filgrastim was based on 1 clinical trial evaluating effectiveness and 3 studies evaluating safety. Effectiveness was established in patients with metastatic breast cancer who were receiving treatment with doxorubicin and docetaxel. A total of 348 patients were randomized to tbo-filgrastim, to placebo, or to a non–FDA-approved filgrastim product. Patients receiving tbo-filgrastim recovered from severe neutropenia in 1.1 days compared with 3.8 days for those patients receiving placebo.
The safety of tbo-filgrastim was established based on 3 clinical studies with 680 patients who had breast cancer, lung cancer, or non-Hodgkin lymphoma who received high-dose chemotherapy that reduces bone marrow cells.
The most common side effect with tbo-filgrastim was bone pain. (August 29, 2012)
