FDA Approved Drugs » 2012
Medical Areas: Hematology | Oncology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Teva Pharmaceutical
Approval Status: Approved August 2012
Treatment Area: severe chemotherapy-induced neutropenia
Neutroval (tbo-filgrastim) is a human granulocyte colony-stimulating factor (G-CSF) produced by recombinant DNA technology. Tbo-filgrastim binds to G-CSF receptors and stimulates proliferation of neutrophils. G-CSF is known to stimulate differentiation commitment and some end-cell functional activation, which increases neutrophil counts and activity.
tbo-filgrastim is specifically approved to reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
tbo-filgrastim is supplied as a solution for subcutaneous injection. The recommended dose of tbo-filgrastim is 5 mcg/kg per day administered as a subcutaneous injection. Administer the first dose of tbo-filgrastim no earlier than 24 hours following myelosuppressive chemotherapy. Do not administer tbo-filgrastim within 24 hours prior to chemotherapy.
FDA ApprovalThe FDA approval of tbo-filgrastim was based on a multinational, multicenter, randomized and controlled study in 348 chemotherapy-naive subjects with high-risk stage II, stage III, or stage IV breast cancer receiving doxorubicin (60 mg/m2) and docetaxel (75 mg/m2). The trial compared tbo-filgrastim to placebo and a non-US-approved filgrastim product as controls. Tbo-filgrastim, placebo, and the non-US-approved filgrastim product were administered at 5 mcg/kg subcutaneously once daily beginning one day after chemotherapy for at least five days and continued to a maximum of 14 days or until an ANC of >10,000x106/L after nadir was reached. Tbo-filgrastim was superior to placebo in duration of severe neutropenia, with a statistically significant reduction in duration (1.1 days versus 3.8 days; p < 0.0001).
Adverse events associated with the use of tbo-filgrastim may include, but are not limited to, the following:
Gatzemeier U, Ciuleanu T, Dediu M, Ganea-Motan E, Lubenau H, Del Giglio A XM02, the first biosimilar G-CSF, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with small cell or non-small cell lung cancer receiving platinum-based chemotherapy. Journal of Thoracic Oncology : official publication of the International Association for the Study of Lung Cancer. 2009 Jun;4(6):736-40
del Giglio A, Eniu A, Ganea-Motan D, Topuzov E, Lubenau H XM02 is superior to placebo and equivalent to Neupogen in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy. BMC cancer 2008 Nov 12;8:332
For additional information regarding Neutroval (tbo-filgrastim) or severe chemotherapy-induced neutropenia, please visit the Teva Pharmaceuticals web page.