HealthDay News — The FDA has approved the drug tbo-filgrastim (Sicor), a short-acting formulation of granulocyte-colony stimulating factor (G-CSF), to treat certain cancer patients undergoing chemotherapy who have severe neutropenia, the agency announced in a press release.
Tbo-filgrastim stimulates the bone marrow to increase neutrophil output. The new drug, which is designed to be injected about 24 hours after chemotherapy is administered, is indicated for adults who do not have cancers of the blood or bone marrow and who are treated with myelosuppressive chemotherapy, according to the FDA.
Tbo-filgrastim received approval after clinical trials showed improved neutropenia recovery rates among 348 adults with advanced breast cancer, who received the chemotherapy drugs doxorubicin and docetaxel. Patients who were admininstered tbo-filgrastim recovered from severe neutropenia in an average of 1.1 days compared with 3.8 days among adults given a placebo.
Bone pain was the most common side effect of the new drug, the FDA said.