THURSDAY, Aug. 30 (HealthDay News) -- The U.S. Food and Drug Administration has approved the drug tbo-filgrastim to treat certain cancer patients undergoing chemotherapy who have a condition called severe neutropenia, the FDA said in a news release.
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Neutropenia, sometimes triggered by certain chemotherapy drugs, is characterized by a decrease in infection-fighting white blood cells called neutrophils. Tbo-filgrastim stimulates the bone marrow to increase output of neutrophils. The new drug, injected about 24 hours after chemotherapy is administered, is meant for adults who do not have cancers of the blood or bone marrow, the FDA said.
Tbo-filgrastim was evaluated among 348 adults with advanced breast cancer who received the chemotherapy drugs doxorubicin and docetaxel. People who received the tbo-filgrastgim recovered from severe neutropenia in an average of 1.1 days, compared with 3.8 days among adults given a placebo, the agency said.
Bone pain was the most common side effect of the new drug observed in clinical testing, the FDA said.
Tbo-filgrastim is produced by Sicor Biotech, a unit of the Israeli pharmaceutical firm Teva Corp.
-- Scott Roberts
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