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FDA NEWS RELEASE

For Immediate Release: Aug. 29, 2012
Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves new treatment for severe neutropenia in certain cancer patients

The U.S. Food and Drug Administration today approved Sicor Biotech’s tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils.

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. This reduction in neutrophils may lead to infection and fever (febrile neutropenia).

Tbo-filgrastim stimulates the bone marrow to increase the production of neutrophils. It is administered as an injection beginning 24 hours after chemotherapy treatment.

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

Tbo-filgrastim was evaluated in a clinical study of 348 adult patients with advanced breast cancer receiving treatment with the anti-cancer drugs doxorubicin and docetaxel. Patients were randomly assigned to receive tbo-filgrastim, a placebo, or a non-U.S.-approved filgrastim product, a drug that also stimulates neutrophil production by the bone marrow. The effectiveness of tbo-filgrastim was determined based on study results that showed that patients receiving tbo-filgrastim recovered from severe neutropenia in 1.1 days compared with 3.8 days in those receiving the placebo.

Tbo-filgrastim’s safety was evaluated in three clinical studies composed of 680 adults with breast cancer, lung cancer, or non-Hodgkin’s lymphoma who received high-dose chemotherapy that reduces bone marrow cells (myeloablative chemotherapy). The most common side effect observed in those receiving tbo-filgrastim was bone pain.

Tbo-filgrastim was approved in an original biologics license application (BLA). FDA has not approved tbo-filgrastim as a biosimilar to Neupogen (filgrastim), which is a previously licensed biological product that contains a related drug substance.

Tbo-filgrastim is manufactured by Sicor Biotech UAB, a member of Teva Corporation.

For more information:

FDA: Office of Hematology and Oncology Products

FDA: Approved Drugs: Questions and Answers 

FDA: Drug Innovation 


This press release was updated on Aug. 31, 2012 at 9:30 a.m. to clarify this product is not a biosimilar.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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