August 29, 2012
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FDA approves treatment for severe neutropenia in cancer patients

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The FDA today approved a product designed to reduce severe neutropenia in cancer patients who undergo chemotherapy.

Tbo-filgrastim (Sicor Biotech) is approved for use in adults who malignancies other than blood or bone marrow cancers.

Chemotherapy drugs often cause neutropenia, a significant decrease in the production of infection-fighting white blood cells called neutrophils. The condition can increase risk for fever or infection.

Tbo-filgrastim — which is administered via injection starting 24 hours after chemotherapy — stimulates the bone marrow to increase production of neutrophils, according to an FDA press release.

“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 Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the release.

The FDA based its approval on results of a study in which 348 adults with advanced breast cancer received treatment with the chemotherapy drugs docetaxel and doxorubicin.

Researchers randomly assigned the patients to receive tbo-filgrastim, a placebo or a non-approved product that also stimulates bone marrow to increase neutrophil production.

Patients assigned to tbo-filgrastim recovered from severe neutropenia within 1.1 days, compared with 3.8 days for patients who were assigned to placebo, according to the FDA release.

The FDA evaluated tbo-filgrastim’s safety based on results of three studies that included a combined 680 adults with breast cancer, lung cancer or non-Hodgkin’s lymphoma. All patients received high-dose chemotherapy, which reduced bone marrow cells.

In those studies, the most common side effect reported by patients who received tbo-filgrastim was bone pain, according to the FDA.