Drug to Decrease Chemo Side Effects Approved

Tbo filgrastim approved by FDA

(RxWiki News) Chemotherapy can hurt the body’s ability to fight off infection. The cancer-killing medicines lower the number of infection-fighting white blood cells. The condition is called neutropenia and another option is now available to treat it.

The US Food and Drug Administration has approved a drug called tbo-filgrastim to battle neutropenia.

"Ask your oncologist about ways to deal with chemo side effects."

It’s approved for patients receiving chemotherapy to treat cancers other than those of the blood and bone marrow.

Tbo-filgrastim helps patients recover more quickly from neutropenia, which can lead to infection and fever.

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

Tbo-filgrastim works by stimulating the bone marrow to make more white blood cells called neutrophils. It is given by injection 24 hours after a chemotherapy session.

The approval comes after a clinical trial involving 348 adult patients with advanced breast cancer. They were receiving the chemotherapy drugs doxorubicin and docetaxel.

Participants were randomly assigned to receive one of three different treatments. They either received tbo-filgrastim, a placebo or an unapproved product that also stimulates the bone marrow..

The trial found that patients receiving tbo-filgrastim recovered from severe neutropenia in 1.1 days compared with 3.8 days among participants getting a sugar pill.

According to the FDA, “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 of the drug was bone pain.

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

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Review Date: 
September 4, 2012