FDA Approves Agent to Shorten Neutropenia Following Chemotherapy

The US Food & Drug Administration is announcing that it has approved tbo-filgrastim for the treatment of the chemotherapy side effect known as neutropenia, (a drop in the body's number of neutrophils, disease-fighting white blood cells). Specifically, tbo-filgrastim is designed to reduce the amount of time cancer chemotherapy patients experience neutropenia.

Neutropenia can be a major problem for cancer patients in treatment as it can make them susceptible to potentially serious infections.

According to the FDA:

"Tbo-filgrastim is intended for use in adults who have cancers other than blood or bone marrow cancers (non-myeloid malignancies) and are taking chemotherapy drugs that cause a substantial decrease in the production of neutrophils in the bone marrow."

Administration of tbo-filgrastim

Tbo-filgrastim works by stimulating the body's bone marrow to boost neutrophil production. It is administered as an injection 24 hours following chemotherapy treatment.

"Supportive care products, such as tbo-filgrastim, reduce or allow for more rapid recovery from side effects of cancer treatments," said Dr. Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Findings from a clinical trial determined that patients receiving tbo-filgrastim recovered from severe neutropenia in 1.1 days, compared with 3.8 days in patients receiving a placebo.

Tbo-filgrastim is a product of Sicor Biotech UAB (part of Teva).

Source: FDA